Manager, IQS Scientific Operations-Novartis Healthcare Pvt. Ltd. -Hyderabad / Secunderabad

Job Description

 

Support operational and functional excellence across IQS functions by focusing on one or more of the following areas: Common processes, practices, and systems to ensure efficiency, quality, compliance and financial support (including definition, implementation and tracking of metrics/KPIs) Review and consolidation of project resource requirements across IQS functions, define internal and external sourcing strategies solutions to best utilize IQS functional capabilities and meet the clinical programs goals in line with departmental budget. Hiring, on boarding, and training programs for IQS functions to attract and develop talents. Knowledge management, communication, and innovation

MSc or equivalent experience in mathematics, statistics, computer science, or health sciences/related field Fluent English required (oral & written) At least 6 years relevant experience (or equivalent breadth of Pharmaceutical experience) including several years in a project functional lead role Good understanding of clinical development, quality and regulatory standards and policies relevant to Data Management, Statistical Reporting, Biostatistics, MedicalWriting (e.g. GCP, ICH) Experience with and good knowledge of the design of randomized controlled clinical trials. Successful experience working in cross-functional teams and management of projects Ability to effectively lead major non-clinical initiatives requiring clinical trial planning, execution, analysis and reporting expertise. High degree of results-orientation and ability to execute Must be able to organize, prioritize and work effectively in a constantly changing environment and motivate the team to do the same Experience in leading operations and innovation Strong communication and collaboration skills. 

 

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Get certification and get employed in clinical research industry.....

Senior Medical Writer-Novartis Healthcare Pvt. Ltd. -Hyderabad / Secunderabad

Job Description

 

To write, edit and/or manage the production of high quality clinical documentation for submission to regulatory authorities in support of marketing applications.

Minimum university life science degree or equivalent Languages: Excellent written and spoken English. Experience/Professional requirement: 1. At least 2 years medicalwriting experience. 2. Good knowledge of statistics and data interpretation and presentation skills. 3. Good knowledge of clinical documentation. 4. Good knowledge of regulatory requirements. 5. Good knowledge of drug development. 

 

APPLY HERE

Associate Medical Writer-Quintiles -Bengaluru/Bangalore

PURPOSE

Assists senior medical writing staff in the preparation of study reports, submissions, or other documents for either internal Quintiles customers or external clients, for investigational drugs, biologicals, or medical devices. Participates in project teams and may lead specific straightforward or small tasks, consulting senior staff as necessary.


RESPONSIBILITIES


Supports Medical Writing senior staff in managing client requests. Examples include but are not limited to the following: writing patient narratives, straightforward bioanalytical study data reports, checking document edits, checking documents for consistency, adapting generic document shells to project specifications, assisting with document compilation, and entering numbers into in-text tables. May also draft text for simple documents, reports or sections of documents or reports, with guidance of senior staff.

Identifies project needs, tracks project timelines and implements client requests, with senior review.

Interacts with internal clients. May have some external interactions, mostly directed by senior staff.

Takes responsibility for managing day-to-day workload for assigned tasks, in collaboration with senior staff.

Keeps abreast of current data, trends, medical and/or technical writing/regulatory knowledge, developments and advances in area of drug development/medical and/or technical writing.

Complies with Company SOPs and participates in the implementation of new SOPs.


REQUIRED KNOWLEDGE, SKILLS AND ABILITIES


Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.

Ability to work on several projects at once while balancing multiple and overlapping timelines.

Ability to assess workload and suggest prioritization to senior staff.

Demonstrated abilities in collaboration with others and independent thought.

Knowledge of regulations relevant to medical/technical writing, such as Good Laboratory Practices (GLP) and other relevant regulatory agencies (e.g. OECD, MHLW).

Careful attention to detail and accuracy.

Must be computer literate.

Ability to establish and maintain effective working relationships with coworkers, managers and clients.


MINIMUM REQUIRED EDUCATION AND EXPERIENCE


Dentistry / BHAMS / M-Pharm with post-graduation in clinical research.Bachelors degree in a life science-related discipline, communications, technical writing, or related field; or equivalent combination of education, training and experience. 1 - 2 years experience in Medical Writing.

APPLY HERE

Opening for Research Associate Toxicology with Evalueserve-Evalueserve.com Pvt. Ltd -Gurgaon

Job Description

To extract, analyse and report data from various toxicology-related databases like TOXNET, HSDB, PubMed, Medline, ScienceDirect etc.
To evaluate quality of different toxicity studies
To identify the critical toxicology data for writing a hazard summary or assessment of a chemical.
To prepare research reports / dossiers according to the international regulatory guidelines


Mandatory Skill Set required

Thorough understanding of various types of basic toxicological principles and toxicological studies
Knowledge of OECD/FDA/EPA guidelines for preclinical toxicity studies
Knowledge of various toxicology/pharmacology databases like TOXNET, ECOTOX, PubMed, e-Chemportal etc.
Knowledge of preclinical safety screening studies as practiced in industry
Good interpersonal skills and communication (both written and verbal) skills
Ability to ensure that tasks within areas of responsibility are completed accurately in a timely manner
Ability to practice attentive and active listening skills
Ability to identify pro-active ways to contribute to firms goals & mission
Challenging current thinking by implementing new ways of working

APPLY HERE

Internship Opportunity....Apply Here

Medical Director | Pune - 1 Opening(s)

Responsibilities:

• Manage a team of Physicians including 3 Managers and overall team of 20+ physicians
• Provide safety management and medical oversight of Pharmacovigilance activities as assigned.
• Identifies, communicates and effectively manages potential safety issues.
• Work closely with Pharmacovigilance colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment
• Ensure regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical safety information
• Provides Investigator support regarding safety concerns, medical emergencies, etc
• Participates in medical safety surveillance/signal detection benefit/risk assessment, and development of trend analyses
• Discusses and resolves medical issues with clinical sites, clients and drug safety staff
• Provide medical review and interpretation for aggregate safety reports (e.g. annual safety reports, PSURs, PADERs)
• Consult with internal and external customers in the area of drug safety.
• Supports business development through participation in core proposal team activities feasibility assessments and review of proposals/contracts for medical services.
• The post holder will perform necessary functions and as directed, any other duties commensurate with the post to ensure the smooth running of operation within the locations(s)
• This job description serves only to give a broad outline of the duties required and will be renewed and amended at periodic intervals in the consultation with the post holder.

Requirements

MBBS / M.D or equivalent degree from an accredited medical school

Currently licensed to practice medicine in one US state, or equivalent in other countries

Minimum 5 years experience in the pharmaceutical, biotechnology or device industry working in Pharmacovigilance/ epidemiology

Minimum 3 years of experience in managing team of physicians

Knowledge of global Pharmacovigilance regulations

Excellent written and verbal communication skills

Computer proficient

APPLY HERE

Pharmacovigilance Alliance Manager- Pharmacovigilance Alliance Manager Novartis Healthcare Pvt. Ltd. -Hyderabad / Secunderabad

Job Description

 

Organises and analyses compliance data for safety information exchange with global license partners and provides root cause analyses for individual cases submitted late to authorities and other non-compliance with global pharmacovigilance agreements. 2. Reconciliation - ensures regular reconciliation of exchanged reports between Novartis & global licensing parties is performed & documented. Communicates any reconciliation issues to PAM, PAH and PPV Head and liaises with PAM to resolve internally and with the license partners. 3. Authors monthly compliance and reconciliation reports, including trend-analyses, for exchange of individual case reports, and other written safety documents between global licensing parties, for both incoming and outgoing information. 4. Alerts PAM; PAH and PPV Head, EU-QPPV and DS&E Operations Management of compliance and reconciliation issues and liaises with PAM, PAH, global operations, DS&E management and license partners to ensure that corrective actions proposed and implemented by the operations groups / license partners are appropriate and effective to improve and maintain a high level of compliance. 5. Argus configuration - regularly reviews expediting requirements and organises verification of corresponding Argus configuration in collaboration with PV-SDM and PAM, as required. 6. Pharmacovigilance agreement updates updates and maintains with PAM, global pharmacovigilance agreements as required.

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Opening for Medical Review/chennai

Hiring for Medical Review

Location Chennai

MBBS /MD candidate.

2-2.5 yrs overall exp( Clinical practice + Medical Reviewer/Clinical  Research/PV)

Open to work in Pharma shifts

Interested candidates can send there resume for support@theverticalrecruiters.in

or can call me at 9582647399 Ankit

 

ctc: 5,00,000 - 8,50,000 P.A

Wanted B.pharmacy & M.pharmacy Freshers for Meddra & WHO DD Coders-Clincorp Technologies Private Limited-Hyderabad / Secunderabad

Job Description

 

CTC: 1,50,000 - 3,25,000 P.A.

Graduates & Postgraduates in Pharmacy with 0 to 3 years of working knowledge in encoding Serious Adverse Events information according to Medical standards may apply. Experience with MedDRA and WHODD coding standards is a prerequisite.

Desired Candidate Profile

Education-

UG: B.Pharma - Pharmacy, BDS - Dentistry, MBBS - Medicine, BHM - Hotel Management
PG:M.Pharma - Pharmacy, M.S/M.D - Any Specialization, Cardiology, Dermatology, ENT, General Practitioner, Gyneocology, Hepatology, Immunology, Microbiology, Neonatal, Nephrology, Urology, Obstretrics, Oncology, Opthalmology, Orthopaedic, Pathology, Pediatrics, Psychiatry, psychology, Radiology, Rheumatology, MVSC - Veterinary Science, PG Diploma - Any Specialization

APPLY HERE

 

Applications are invited for internship.....

Walk-in Interviews for Advanced/senior Associates-non-voice Process!!!-

Job Description:

Xchanging is conducting, Walk-in interviews  from Monday 27th April 2015 to Thursday 30th April 2015  for its  Healthcare Business , BPO division -Whitefield Bangalore.
Interview Timing : 10:00 AM to 1:00 PM
Contact Person : Carol Fernandes
"Carry a copy of this ad along with your CV."


Interview Venue :
Xchanging
Xchanging Towers, SJR I-Park,
EPIP Area, Whitefield, Opp Satya Sai Hospital,
Bangalore - 560066. India.  
The candidate is accountable for :

Need to create orders for the Injured Patients.
Understand the different body parts and creating the orders without any defects.
Ensuring the right interpretation is done based on the prescription, which we are receiving from the Doctor/Hospitals.
Ability to record patient observations accurately and report any issues or concerns immediately to the TL.
Typing speed of minimum 35 WPM.

Preferred Candidate Profile
Excellent Communication Skills
Voice Process, making outbound calls.
Should be able to work under unpredictable circumstances.

Requisites
Degree in B.Sc.(Biology)or Candidates with Health Care work experience.
Experience with International voice process.
Willing to work in global shifts 

Walkin - in Interview in Chennai on 9th MAY 2015( Job Loc'n: Blore)-Quintiles

CTC: 2,00,000 - 7,00,000 P.A 

Job Description

 

 QUINTILES Walk - in interview in CHENNAI Location on  9th May 2015 (position based out of Bangalore)

Desired Profile :

Candidates with experience from 2 to 7 years in Clinical Research /CRC / CPC / CTA /Lab/ Clinical trails  are welcome.
Excellent Communication skill is mandatory.
Willing to work in shift.



Interview Venue Details
The Pride Hotel, 216, EVR Periyar Salai, Kilpauk, Chennai - 600 010.
Contact Person: Kikali/Thenmozhi/Padma
Time : 8.00AM

Clinical Research Associate- Clinical Research Associate-Navi Mumbai, Ahmedabad

Job Description

 

Job Responsibilities:
Conduct Site Initiation Visits (SIV), conduct Protocol, ICH-GCP and SOP training at sites, demonstrate study procedures including Source Templates Filing, Annotated CRFs & CRF filling instructions (Paper/EDC), Informed Consent procedures, Patient Screening & Eligibility procedures, IP Handling procedures, Safety Reporting & Unblinding procedures etc. to investigators and CRCs, ensure timely SIV reporting & follow-up letters
Conduct routine Site Monitoring Visits (SMV) to clinical sites, do Source Doc Verification, review Site Master Files (SMFs), relevant study and patient records, resolve open site issues, ensure timely SMV reporting and follow-up letters
Verify Clinical Supplies Inventory and IP Management procedures at site and ensure complete and accurate drug accountability
Ensure Protocol Compliance in execution of trials, identify, document and resolve protocol deviations and violations, informed consent deviations and issue/action log
Ensure compliance to ICH-GCP, Indian GCP / Schedule Y and other applicable regulatory standards
Review communication of site with IRB/EC and other regulatory bodies
Act as Lead Monitor, maintain contact with site personnel and ensure timely resolution for study specific queries as well as proper escalation of site/project related issues to sponsor
Maintain audit readiness at the site level for any audits or regulatory inspections
Conduct site/study close-out activities and assure appropriate archival of controlled documents and retrieval of CRFs, Clinical Supplies and other relevant study materials
Compile and review weekly and monthly project metrics relating to study conduct e.g. Patient Screening, Recruitment & Drop-outs, Subject Logs, Safety Logs, CRF Retrieval status etc.
Manage and provide oversight to New Study Feasibilities including site feasibilities and qualification

APPLY HERE

Join Clinical Research I Pharmacovigilance I Clinical Data Management I Regulatory Affairs industry

Senior Medical Writer-Cactus Communications Pvt. Ltd. -Mumbai

Job Description

 

Send me Jobs like this

The Medical Writing team at Cactus offers medical writing services to multinational pharma, clinical research organizations, and researchers worldwide. We work with clinicians and researchers to help them communicate their science to the world. We are currently looking to add to our team of medical writers, experienced researchers, preferably post docs looking to work in non-lab setting, aspire to be part of a world-class delivery team, and work in an exciting, fast-paced global environment. Visit http://www.cactusmed.com (USA) or http://www.cactusglobal.com (India) for further details.

What is a typical day at work like?



• Ensure timely production of high quality documents (manuscripts, abstracts, short communications, review articles) for publications in journals or for presentation in meetings and other written communication material supporting pharmaceutical brands, research activities, and business needs
• Prepare documents that are publication ready
• Review work done by team members and provide appropriate feedback
• Liaise with internal and external stakeholders, including authors & KOLs
• Act as document specialist and provide intellectual input across document types
• Provide quality-related coaching or mentoring to team members, as appropriate
• Develop and maintain necessary templates, formats and styles to ensure that documents generated meet industry, internal, and client requirements
 


APPLY HERE

Medical Writing - Trainee ( Fresher )-Quintiles -Bengaluru/Bangalore

Job Description

 

 PURPOSE
Assists senior medical writing staff in the preparation of study reports, submissions, or other documents for either internal Quintiles customers or external clients, for investigational drugs, biologicals, or medical devices. Participates in project teams and may lead specific straightforward or small tasks, consulting senior staff as necessary.

RESPONSIBILITIES

Supports Medical Writing senior staff in managing client requests. Examples include but are not limited to the following: writing patient narratives, straightforward bioanalytical study data reports, checking document edits, checking documents for consistency, adapting generic document shells to project specifications, assisting with document compilation, and entering numbers into in-text tables. May also draft text for simple documents, reports or sections of documents or reports, with guidance of senior staff.
Identifies project needs, tracks project timelines and implements client requests, with senior review.
Interacts with internal clients. May have some external interactions, mostly directed by senior staff.
Takes responsibility for managing day-to-day workload for assigned tasks, in collaboration with senior staff.
Keeps abreast of current data, trends, medical and/or technical writing/regulatory knowledge, developments and advances in area of drug development/medical and/or technical writing.
Complies with Company SOPs and participates in the implementation of new SOPs.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
Ability to work on several projects at once while balancing multiple and overlapping timelines.
Ability to assess workload and suggest prioritization to senior staff.
Demonstrated abilities in collaboration with others and independent thought.
Knowledge of regulations relevant to medical/technical writing, such as Good Laboratory Practices (GLP) and other relevant regulatory agencies (e.g. OECD, MHLW).
Careful attention to detail and accuracy.
Must be computer literate.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Dentistry / BHAMS / M-Pharm with post-graduation in clinical research.Bachelors degree in a life science-related discipline, communications, technical writing, or related field; or equivalent combination of education, training and experience. FRESHER

APPLY HERE

Do your certification in this summer....Apply for it..get employed into Drug Development industry

https://docs.google.com/forms/d/1baiHTKl7RYEjJmlndx6sxCJh4CmRYbIVtofs03gwM3g/viewform

Indian Biosimilars Market

India is one of the biggest sources of generic industry and is one of the emerging markets with its high population and investment in technology. Although India does not have stringent regulations, the country has a big potential for biosimilars… 
If we have a look at the sales figures of Indian biosimilars, 200 million US dollars of sales was recorded in 2008. But according to the analysts, the market will grow to 580 mUSD in 2012, which means a CAGR +30%.
REGISTRATION OF BIOSIMILARS
As described, India is a semi-regulated market and no phase I/II studies are required for biosimilars. To conduct a phase III study is a mandatory step and minimum 100 patients are needed for this study.
Due to the legislation and the environment in the country, the development of a biosimilar can be between 10-20 mUSD in India, much cheaper than the fully regulated countries. And with this regard, the price of a biosimilar, can be 25-40% cheaper than the originator.

Read More

Advanced drug delivery systems: Nanotechnology of health design A review

Nanotechnology has finally and firmly entered the realm of drug delivery. Performances of intelligent drug delivery systems are continuously improved with the purpose to maximize therapeutic activity and to minimize undesirable side-effects. This review describes the advanced drug delivery systems based on micelles, polymeric nanoparticles, and dendrimers. Polymeric carbon nanotubes and many others demonstrate a broad variety of useful properties. This review emphasizes the main requirements for developing new nanotech-nology-based drug delivery systems.

Read more

Research Coordinator-LV PRASAD EYE INSTITUTE -Hyderabad / Secunderabad

CTC: 2,50,000 - 3,75,000 P.A 

Job Description

 

1. Prepares study materials including ethical committee or regulatory submission documents, enrollment logs, adverse event reports, and staff training materials.
2. May assist in recruitment, training and supervision of research staff.
3. All communications related to project with partners and funding agencies.
4. Prepare reports financial, project progress etc.
5. Arrange, organize, communicate and prepare minutes of research group.
6. The project involves conducting workshops. It will involve arranging venue, communicating with participants, travel and lodging arrangements etc.
7. Maintaining all study files.
8. Back up of all E-research data.
9. Internal communicates- finance, progress reports; publication etc.

Desired Candidate Profile

Education-

UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy

APPLY HERE

HOS Data Entry-any Grad-Accenture-Chennai

Job Description

Schedule : Full-time

Responsible for the review and validation of eligibility information received from the customer as well as the data-entering of this information into the client system.
Responsibilities/Authorities :

? Complete review of enrollment forms
? Identify missing information on forms
? Send incomplete forms back to client
? Complete and forward outgoing correspondence when required
? Key enrollment forms into client eligibility system
? Maintain customer eligibility information
? Review and analyze specific eligibility report
? Maintain and track individual workflow and production
? Support inventory control during peak times or as needed
? Processes faxed eligibility maintenance requests initiated by Customer Calls
? Process urgent requests
Requirements:
? University degree or equivalent.
? At least 6 months experience as a Processing Assistant preferred, but not required
? Outsourcing operations experience preferred, but not required
? Working knowledge and experience with computers and internet
? Technical or Specific Skills (e.g. technical, computer)
? Basic technical knowledge
? A working knowledge of MS Office products
? Proficient in report writing, business correspondence
? Strong Excel skills

Mandatory Requirement

1. At least 6 to 12 months work experience in healthcare domain as per required domain
a. Claims
b. Billing Function
c. Enrollment
2. Should have past experience working in night shift
3. Should be open to working in night shift
4. Good English comprehension -- verbal and written
5. Simple analytical skills
6. Good typing skills, at least 30 wpm at 95% accuracy
7. Residence should be within Accenture Transport Boundary
8. Should at least be a graduate

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Clinical Research Associate-Manipal Acunova Ltd.-Bengaluru/Bangalore

Job Description

 

The responsibility of a Clinical Research Associate (CRA) is to perform all clinical monitoring aspects of designated projects in accordance with applicable SOP and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, and data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.

Preparation of Site feasibility questionnaire, conducting the feasibility and reporting to PM
Preparation, conduct and reporting of site selection visits
Negotiation & obtaining Investigator agreement on site budget, payment to the sites
Development/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents
Procuring essential documents from sites, their QC and filing in a timely manner and updating project tracker or sending the documents to PA for filing in a timely manner
Maintenance of TMF and Site specific file
Scanning & uploading documents into shared drive
Transmission of documentation into project files
Preparation of regulatory dossier, regulatory submission and follow-up.
Preparation of EC dossier, EC submissions and follow-up
Co-ordinating arrangements for the investigators meeting, acting as a host for this meeting
Development of meeting materials along with required presentations for investigators meeting.
Site initiation visit planning, preparation, conduct, report and follow-up of pending issues
Co-ordinating the IP request between sites and pharmacist/vendor/sponsor

Desired Candidate Profile

Education-

UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required

Worked in OPHTHALMOLOGY or ONCOLOGY or DIABETES studies Clinical Studies I-IV
Ability to interact professionally with clients/vendors
Excellent interpersonal, verbal and written communication skills and ability to work in a team
Effective time management skills and prioritize tasks to manage study timelines
Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word etc, sound presentation skills
Willing to travel a minimum of 65% on average



APPLY HERE

Research / Clinical / Medical / Non Clinical / US Healthcare - 10 Opening(s)-Hyderabad / Secunderabad

ESSENTIAL JOB RESPONSIBILITIES:

Accurately responding to research related queries and proposing suggestions for rule changes if applicable.
Develop potential rules that can be applied for iHT clients to adjudicate claims accurately relative to medical policy. Review State Medicaid guidelines to identify possibility of inappropriate edits for Medicaid claims.

RELEVANT EXPERIENCE & EDUCATIONAL REQUIREMENTS

- Medical degree (MBBS or MD) / Certified medical coder / BHMS / BAMS
- Clinical experience is a must
- Clearance of all major exams (SSC, HSC, qualifying degree) in first attempt
- Clearance of cognitive aptitude test analytical, quantitative, and logical reasoning skills
- Experience in private sector/ Health plan operations with focus on reimbursement and/or claims processing and/or medical coding preferred
- Knowledge of ICD-10 coding preferred 

Contact Person: Mohsin

APPLY HERE

Apply For Summer Internship....

Start your Research and Development career now.....

Submission Writer-Novartis Healthcare Pvt. Ltd. -Hyderabad / Secunderabad

Job Description

 

1. To author, review and independently manage high quality clinical and safety documents: non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registry Database (CTRD), Risk Management Plans (RMP), Periodic Safety Update Reports (PSUR). 2. Lead for outsourced Narrative projects. Coordinate other outsourced activities in OSM. 3. Core member of Clinical Trial Team (CTT)/ participate in Safety Management Team (SMT). 4. Actively participate in planning of data analyses and presentation to be used in CSRs. 5. Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines. 6. May act as Program Writer ensuring adequate medicalwriting resources are available for assigned program and consistency between documents. 7. Act as liaison between CTTs, CSTs and publishing teams to ensure timely delivery of final documents for publishing. 8. Support the development of OSM through participating in OSM initiatives and other related activities. 9. Contribute to development of processes within OSM. May contribute to cross-functional initiatives. 10. Fostering cross-functional communication to optimize feed-back and input towards high quality documents. 11. Maintain audit, SOP and training compliance.

Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable. Fluent English (oral and written). HYDERABAD ONLY: Masters with 3-5 years of relevant experience. PhD or degree in medicine (MBBS/MD or Alternative medicine) with 1-3 years of relevant experience 2 years medicalwriting experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medicalwriting processes. Excellent communication skills (written, verbal, presentations) Operational knowledge of clinical trial reporting. Very good understanding of biostatistics principles. Ability to prioritize and manage multiple demands and projects. Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements). Ability to define and solve complex problems (Problem-solver) Broad knowledge and future oriented perspective Proven track record in matrix environment Experience in contributing to global, cross functional projects.

APPLY HERE

Document Review Team Lead-Bengaluru/Bangalore, Mumbai, Delhi-PPD

Job Description

Due to continued growth, PPD is recruiting for a Document Review Team Lead to join our Global Medical Writing team.

Responsibilities:

Supervises the overall operational activities of project(s) within the Document Review group including but not limited to: Provide short-term and long-term resource planning in order to assign project activities to appropriate and available staff. Hold regularly scheduled meetings with staff and provide updates to senior management. Assist staff to forecast project-related timelines for completion. Hires and evaluates employees. Recommends salary levels and promotions.

Oversees the preparation of Document Review deliverables and may serve as lead reviewer on large review projects. Organizes processes for completion of projects within established timelines. Evaluate timeliness and quality of deliverables and provide updates to senior management. Provide input and review group SOPs and WPDs; evaluates compliance with SOP/WPD on an ongoing basis. Builds client relationships, identifies, and resolves complex client management issues.

May support marketing presentations to potential clients on the capabilities of the Document Review group.
Provides input on training programs for Document Review. Ensures that reviewers on assigned project are adequately trained in document review skills.

Qualification Required:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years) or equivalent and relevant combination of education, training, & experience.
1+ year of leadership responsibility

Knowledge, Skills & Abilities:

Experience mentoring personnel and coordinating the work of project teams
Ability to supervise, evaluate, and mentor departmental personnel
Ability to delegate tasks and facilitate completion of assignments
Effective management skills, including the ability to create and modify budgets, project timelines, allocate resources, and forecast departmental workload
Demonstrated innovation in developing new ideas related to process improvements
Strong document and quality review knowledge
Proficient in Microsoft (MS) Word and MS Excel
Advanced organizational, analytical and interpersonal skills to manage several complex projects in parallel and manage rapidly changing priorities
Ability to independently assess client needs and work with project team members in producing compliant deliverables
Ability to independently learn new technologies
Advanced editorial/proofreading skills
Strong leadership to a diverse staff
Ability to work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables
Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results

Desired Profile

Education:UG -Any Graduate - Any Specialization, Graduation Not Required
PG - Any Postgraduate - Any Specialization, M.Sc - Any Specialization, Chemistry, Biology, Statistics, M.Pharma - Pharmacy

APPLY HERE

H and LS Medical Writer- 4 - 6 YearsChennai-Accenture

Job Description Schedule : Full-time

Ph.D. in Life Sciences or Pharmacy/M.D. in Pharmacology or Physiology or Public Health/ M.B.B.S./ B.D.S./ B.A.M.S with 4 to 6 years of experience in clinical development including supporting/ leading activities related to reconciling, writing, editing and/or managing the production of high quality clinical documents that are components of regulatory marketing approval may apply.

APPLY HERE

Walk-in @ Quintiles for PV on 25-apr-2015(fresher & Experienced)-Bengaluru/Bangalore

Job Description

 

Hi,

Greetings from Quintiles!!!

We are hiring candidates for Pharmacovigilance Positions.

Its an exclusive walk-in event for both freshers and experienced on Saturday, 25th Apr 2015.

Timings: 8:00 AM

Interview Venue Details

Quintiles Research India Pvt Ltd.

Prestige Technologies Park ll,
Etamin Block, 3rd floor, B-wing,
Sarjapur-Marathalli Outer Ring Road,
Bangalore-560 103
Landmark: J.P Morgan company, same campus last block

Contact: Shamshuddin/Kavya L

Requirement : Candidates only with Life Science background with good knowledge in Pharmacovigilance can apply.

RESPONSIBILITIES
To Prioritize and complete the assigned trainings on time.
Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information; determining initial/update status of incoming events; database entry; coding AE and Products, writing narratives, Literature related activities.
Assuming other workflow responsibilities for the assigned project as directed by Operations team member or Manager.
Ensure to meet the expected productivity and quality standards
Ability to identify quality problems, if any, and bring them to the attention of a senior team member/ mentor.
Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
Perform other duties as assigned.

Desired Candidate Profile

Education-

UG: B.Sc - Any Specialization, Any Specialization, Any Specialization, B.Pharma - Pharmacy, Pharmacy, Pharmacy, BDS - Dentistry, Dentistry, Dentistry
PG:Post Graduation Not Required, M.Sc - Any Specialization, Anthropology, Bio-Chemistry, Biology, Botany, Nursing, Zoology, Other, M.Pharma - Pharmacy, M.Tech - Any Specialization, Bio-Chemistry/Bio-Technology, Biomedical

Pharmacovigilance Practice Head - IMS Health-Bengaluru/Bangalore, Gurgaon

Job Description

 

Role Purpose:

Grow and manage the pharmacovigilance (PV) services delivery practice at IMS Healths Global Delivery Center (across Bangalore, Gurgaon, and Colombo offices)

Principal Accountabilities:

Enable pharmacovigilance/adverse events tracking (PV/AE) business deals by supporting the onshore teams in the sales cycle, through building/enhancing suitable collateral for the practice, including pitch decks, proposals, project plans, audit plans, SOPs, etc.
Manage the PV team across different locations
Liaise with technology team to drive the PV/AE engagements successfully, and leverage automation to enhance productivity as well as quality
Ensure all projects are managed with pristine quality, and within the timelines agreed upon
Drive operational excellence in the PV practice, and streamline PV processes
Drive the culture of metrics and reporting these on a periodic basis, to enhance the quality and operational rigor of the practice
Ensure rigor in documentation and establish best practices
Track resourcing and profitability on engagements
Prepare the team for pharma company PV audits and to successfully undergo these audits
Establish processes for training as well as certifications required for the PV practice
Hire smart candidates (fitness for purpose) and groom them
Drive productivity, smart processes, and policies
Drive thought leadership and innovation 

Minimum Education, Experience & Specialized Knowledge Required:

Educational requirements Life Sciences degree, preferably B.Pharm + M.Pharm (or B.Pharm + MBA), or MBBS from a reputed institute, with respectable scores throughout the academic career
10+ years of experience in pharmacovigilance (post-marketing surveillance experience is highly necessary as opposed to AE tracking in clinical trials)
Experience in both agency/vendor/partner (must-have) and pharma (good-to-have) preferred
Experience of driving the preparation for audits, and successfully undergoing stringent audits by pharma companies as a PV agency/partner to a pharma company
Training certifications in pharmacovigilance/adverse events tracking
Excellent communication skills
Experience in onshore/offshore model preferred
Knowledge of and exposure to unstructured data/social media data would be a plus
High comfort level and affinity to using technology tools in the field of adverse events tracking
Drive for excellence in work, passion for quality, ability to operate at scale without compromising quality, team building and leadership abilities
Social adaptability, willingness to adapt to international cultures, work environments and business processes

Additional Requirements:

Excellent presentation skills
Drive for perfection, strong attention to detail, and impeccability in delivering publishable output
Ability to communicate effectively in a complex global business set up since the job will involve routine interaction with international stakeholders
The candidate should be willing to go through assessment tests and series of interviews, which are, as a practice, administered for recruitment across all levels (including senior-most) in the Nexxus Social Media team, of which the PV team is an integral part.

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Clinical Research Coordinator TECH OBSERVER 1 - 2 yrs Mumbai

CTC: 1,25,000 - 1,50,000 P.A
Job Description

Recruitment,coordination & follow up of trial subjects, covering informed consent, adhering to safety and compliance issues;sample collection & shipment;Administer study drug;Coordination & management of Clinical Trial;

Salary: 1,25,000 - 1,50,000 P.A

Role Category:R&D

Role:Clinical Research Associate/Scientist

Desired Candidate Profile

Education-

UG: B.Pharma - Pharmacy, B.Sc - Any Specialization

PG:Post Graduation Not Required, M.Pharma - Pharmacy, M.Sc - Any Specialization

Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required

    Good Communication skills
    Willing to travel within City

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Walkin - in Interview in Quintiles on 25th April 2015 Quintiles -2 - 7 yrs Bengaluru/Bangalore

 

CTC: 2,00,000 - 7,00,000 P.A 

Job Description

 

 Walk-in Interview in Quintiles on 25th April 2015.

Desired Profile :

Candidates with experience from 2 to 7 years in Clinical Research /CRC / CPC / CTA /Lab/ Clinical trails  are welcome.
Excellent Communication skill is mandatory.
Willing to work in shift.



Venue Details
Wing A, GroundFloor, Etamin Block,
Prestige Technology Park II
Sarjapur  Marathahalli, Outer Ring Road,
Bangalore - 560103.
Contact Person: Sudhamani/Thenmozhi
Time : 8.00AM

 

Salary: 2,00,000 - 7,00,000 P.A
Role:Clinical Research Associate/Scientist

Desired Candidate Profile

Education-

UG: Any Graduate - Any Specialization, Graduation Not Required
PG:Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required

Get knowledge and experience together-Get Employed with CRO, Bio-pharma and IT Life Science Org.

Research Scientist- Microbiology & Genetics/biotechnology-Bhopal

Job Description

 

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Job Summary

Research scientist will work in a dynamic, fast-paced, team-oriented and collaborative environment to be part of our success. This candidate will use their skills and knowledge in Microbiology, Genetics, Molecular Biology, Virology and Bacteriology to develop and optimize new products.

Job Description

- Design, execution and coordinate in vitro enzymatic and cell based assays.
- Manipulate microbial genetic material for the development of new products.
- Develop and perform small scale fermentation studies.
- Conduct analysis of pharmaceutical and biologic products using traditional microbiological techniques such as dilution, pour plating, and filtration.
- Perform a wide range of general Microbiology and Molecular testing to include: PCR, PCR design, primer design, PCR optimization, DNA extraction from bacteria, DNA sequencing, DNA gel electrophoresis, protein extraction, BCA assay, PAGE, Western blotting, Western blot optimization, silver staining, antibody sourcing, bacteriology and fermentation.
- Candidate may also perform: cloning, subcloning, restriction digests, ligations, transformations, Southern blots and protein expression.
- Culturing bacterial and mammalian cell lines. Collect, analyze and present data at both internal meetings with other scientists and collaborators as well as at external scientific meetings.
-Perform program/project management tasks to facilitate pre-clinical to clinical development of vaccine candidates.
- Interface with external research collaborators to manage pre-clinical research studies.
- Responsible for preparation of study protocols, reports and reports for regulatory filings for product development.
- Monitor critical study phases at CROs to ensure protocol adherence and compliance with GLP standards, as necessary.
- Prepare study design, study data, and program updates.
- Work with cross functional development group to bring research stage molecules to market.
- Independently review the scientific literature for advances in product development.
-Assist in preparation of Preclinical study design and Plans.
- Analysis of the data from those studies.
- Review reports for finalization.
-Capable to write up of manuscript and publish the research work.

Desired Candidate Profile

Education-

UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy, M.Sc - Bio-Chemistry, Biology, Microbiology
Doctorate:Ph.D - Pharmacy, Bio-Chemistry/Bio-Technology, Biotechnology, Microbiology
 

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Preclinical Research Scientist-Bhopal

Job Description

 

Job Summary

Preclinical research scientist will work in a dynamic, fast-paced, team-oriented and collaborative environment to be part of our success. This will include establishing the capabilities for testing of products in preclinical models and/or managing CRO studies aimed at providing proof of concept.

Job Description

- Design, execution and coordinate in vitro/ in vivo Pharmacology, DMPK & Toxicology studies including critical tips/suggestions in life phase of experiments, cross checking the raw data files, draft and final report reviewing and discussing the study results to intra- department teams, and project team members.
- Develop in vitro and in vivo animal model systems and techniques to evaluate efficacy and mechanism of action of nutraceuticals/pharmaceutical products.
- Monitor critical study phases at CROs to ensure protocol adherence and compliance with GLP standards, as necessary.
- Present study design, study data, and program updates.
- Support integrated project goals; pro-active role for departmental budget and timeline commitment, provide technical and professional advice to junior scientists.
- Work with cross functional development group to bring research stage molecules to market.
- Independently review the scientific literature for advances in model development.
-Assist in preparation of Preclinical Safety Development Plans.
- Analysis of the data from those studies.
- Review reports for finalization.
-Write up of manuscript and publish the research work.

Desired Candidate Profile

Education-

UG: B.Sc - Bio-Chemistry, Biology, B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy, M.Sc - Any Specialization, Bio-Chemistry
Doctorate:Ph.D - Bio-Chemistry/Bio-Technology, Biotechnology, Pharmacy

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Research Associate -analytical Formulations @ Alembic Research Centre

Job Description 
1. Development of analytical methods such as Assay, Related Substances, Dissolution for new formulations for solid orals formulations.
2. Identification of unknown impurities in stability samples using LCMS/MSMS
3. Responsible for resolving issues occur during routine analysis and stability studies.
4. Generation, isolation and charactisation of unknown impurities crossing identification threshold using LCMS.
5. Complete analysis of generic drug products targeted for US,UK market.
6. Trouble shooting in method development.
7. Calibration of analytical Instruments i.e. LCMS, HPLC, UPLC.
8. Preparation of method transfer sheets and standard test procedures.
9. Ensuring regulatory compliance by maintaining of appropriate requisite documentation/record

Experience	2 - 5 Years
Industry Type	Pharma / Biotech / Clinical Research
Role	Analytical Chemistry Associate/Scientist
Functional Area	Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Education	UG - B.Sc - Any Specialization, Chemistry, B.Pharma - Pharmacy PG - M.Sc - Any Specialization, Chemistry, M.Pharma - Pharmacy Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Compensation:	Not disclosed
Location	Vadodara/Baroda
Keywords	Assay Dissolution Method Development
Contact	Human Resources Alembic Pharmaceuticals Limited
Website	http://www.alembic-india.com
Job Posted	2015-04-21 12:12:04.0

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Research Executive (Phd Organic Chemistry)-Mumbai

CTC : 3,50,000 - 6,00,000 P.A 

Job Description

 

Running & monitoring chemical reactions, work up, isolation and characterization of products.
Synthesis of various multi step agrochemicals/PGR/intermediates
Maintaining chemical inventory, taking care of lab, equipment's/instruments 

 

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Manager Global Primary Research - Noida

CTC: 7,00,000 - 12,00,000 P.A 

Job Description

 

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• Responsible for healthcare / pharmaceutical / medical devices primary research operations end to end
• Managing and mentoring a team of analysts/lead analysts for various global telephone primary research projects
• Responsible for managing top lines and bottom lines for healthcare primary research vertical
• Responsible for smooth delivery of primary research projects end to end
• Manage client accounts from a relationship perspective
• Drafting project scope (business proposal) as per client's requirements, studying, analyzing and estimating effort required for execution
• Understand research objectives based on client type and accordingly design/define the work approach; project scope and timelines
• Develop work plan for projects with a visibility on client engagement process, interim deliverable, etc. in an organized manner as per prioritization
• Responsible for the quality of the work being done in the team; review work thoroughly to ensure consistently high quality output, value addition and adherence to timelines; be able to judge required level of own involvement on projects, execute parts of projects if situation so demands
• Provide analysts with effective verbal/ written feedback; counsel analysts on technical as well as business skills and guide them on best practices
• Contribute to different organisational tasks such as hiring, training and other organisational initiatives

Desired Candidate Profile

• Strong educational background in pharmacy, biotech, life sciences, biomedical or clinical research
• 2-3 years of experience in managing teams and projects for healthcare/pharma primary market research through CATI (Telephone)
• Demonstrated skills in both people management and client management
• Experience in business development is a plus

How to Apply?
Email your resume with Subject : Manager Global Primary Research (Healthcare, pharmaceuticals, medical devices) - Noida (Job Id : 2283) to : jobs@thesearchhouse.com

After Emailing your resume you may call : 9811112343

View more jobs matching your profile on The Search House website. http://www.thesearchhouse.com

Desired Candidate Profile

Education-

UG: B.Tech/B.E. - Any Specialization, B.Pharma - Pharmacy

Recruiter Name:Jyoti
Email Address:
Website:http://www.thesearchhouse.com
Telephone:9811112343

Research Associate/ Content Writer-Hyderabad / Secunderabad

CTC: 1,50,000 - 2,00,000 P.A

Job Description

• Content writing for spectrum / Pharmaplus books
• Preparing copy right free material/ books.
• Preparing Content for MBA, B.Tech (all streams), Competitive books/ Materials.
• Content to be written in easy, meaningful and as per the requirements of the students.

Desired Candidate Profile

UG: B.Tech/B.E. - Any Specialization, Civil, Computers, Electrical, Electronics/Telecommunication, Mechanical, B.Pharma - Pharmacy, B.Com - Commerce
PG:MBA/PGDM - Finance, HR/Industrial Relations, Marketing, M.Tech - Any Specialization, M.Sc - Any Specialization, Chemistry, Maths, Physics, M.Pharma - Pharmacy

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Research Associate - Analytical R&D ( Male )-Hyderabad / Secunderabad

CTC: 1,00,000 - 4,00,000 P.A 

Job Description

 

Knowledge of analytical method development, Validation and stability analysis of Oral and Injectable dosage forms.
Handling of dissolution apparatus for Tablets, Capsules, Oral Liquids and Oral Suspensions.USP Type-I, USP Type-II & USP Type-IV.
Knowledge about the handling of analytical instruments like HPLC,GC, UV,SOR,IR,Particle size analyser,Osmometer,viscometer etc.
Knowledge about the calibration of HPLC,GC,UV,SOR,IR,Particle size analyser,Osmometer,viscometer etc.
Knowledge about regulatory guidelines and requirements.
Knowledge about method transfer activities.
Knowledge about the safety aspects.
Knowledge about GLP and GMP.
Knowledge about the qualification of equipment and instruments.
Qualification M.Pharm./M.Sc. (Analytical Chemistry/Organic Chemistry)
Forward CV's : ideal9@idealconsultants.com/ call at 9989059750

Research Associate - Formulation R&D ( Male )-Hyderabad / Secunderabad

CTC; 1,00,000 - 4,00,000 P.A 

Job Description

 

Knowledge of Oral and Injectable dosage forms.
Handling of Tablets, Capsules, Oral Liquids and Oral Suspensions.
Handling of Injectable Liquid and Lyophilized Formulations.
Knowledge about the handling of Cytotoxic materials.
Knowledge about the safety aspects.
Knowledge about GLP and GMP.
Knowledge about the qualification of equiment and instruments.
Knowledge about regulatory guidelines and requirements. Candidate Should have experience in pharma Industry
Qualification M.Pharmacy (Pharmaceutics/Industrial Pharmacy)

Forward CV's : ideal9@idealconsultants.com/ call at 9989059750

Research Associate/sr. Research Associate - Bio Analytical-Macleods Pharmaceuticals Ltd.-Mumbai

CTC : 2,00,000 - 4,00,000 P.A 

Job Description

 

Bio-analytical method development and method validation using LC-MS/MS.

LC-MS/MS method development
Data analysis and report preparation of Bio analytical and ADME studies
Documentation and accountable for overall scientific data and reports
Review of Method Validation reports and Bioanalytical report

Desired Candidate Profile

Education-

UG: B.Pharma - Pharmacy
PG:Any Postgraduate - Any Specialization, Post Graduation Not Required, M.Pharma - Pharmacy

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J&J to increase wearable insulin patch-pump production

Johnson & Johnson will scale up manufacturing of a three-day wearable patch pump used to deliver insulin, in preparation for a post 2016 launch.

http://www.in-pharmatechnologist.com/Drug-Delivery/J-J-to-increase-wearable-insulin-patch-pump-production

Anti-fungal shows promise for cancer breakthrough in preclinical tests

An anti-fungal drug shows potential to treat a range of cancers, according to research from the Repurposing Drugs in Oncology (ReDO) project, but the drugmakers will need a financial incentive to pursue a licence for new indications.

http://www.in-pharmatechnologist.com/Ingredients/Anti-fungal-shows-promise-for-cancer-breakthrough-in-preclinical-tests

PPD pushes further into Asia with new Chinese central lab

CRO Pharmaceutical Product Development (PPD) has opened a central laboratory in Shanghai, China, in order to meet growing client demand for scientific and technical services there.

http://www.outsourcing-pharma.com/Commercial-Services/PPD-pushes-further-into-Asia-with-new-Chinese-central-lab

HLS and Harlan create hairless mouse model

Huntingdon Life Sciences and Harlan Laboratories have launched a highly immunocompromised hairless mouse model for oncology and immunology research.

Read More at

http://www.outsourcing-pharma.com/Preclinical-Research/HLS-and-Harlan-create-hairless-mouse-model

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Clinical Data Manager I-Bengaluru/Bangalore-PPD

ob Description The objective of a Clinical Data Manager I is to act as the lead data manager for one or more projects or to provide support to the lead data manager. CDM I's will lead all data management activities for individual, limited volume/complexity studies with mentoring from a manager as required. CDM I's work independently and efficiently perform, with quality, all data management activities within an assigned study. CDM I's may mentor junior level staff on all associated tasks within a study. CDM I's liaise with the sponsor as required and communicate with management regarding all data management activities within their studies. Responsibilities include:
Ensures database accuracy according to departmental operating procedures
Performs a QC review of the data and makes corrections to the DM database
Develops data validation manual
Defines and tests databases and data validation system
Represents Data Management in all cross functional meetings relating to the study
Reviews data listings for consistency and accuracy of data
Develops and maintains data management project documentation files
Performs independent reviews of data management deliverables following documented guidelines
Acts as an interdepartmental and sponsor liaison for all DM study activities
Produces project-specific status reports for management and sponsors
Monitors study metrics
Analyzes and resolves discrepancies in data validation or other reports

Education and Experience:
Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)
Minimum 3 years work experience in a professional environment, preferably within a clinical or medical data environment, including 2 years of data management experience
Or a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily

Desired Profile

Education:UG -Any Graduate - Any Specialization, Graduation Not Required
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required

 

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