Viral clearance studies are mandated prior to entering clinical trials
and for commercial launch of biopharmaceuticals. These studies are a
key component of risk mitigation to reduce the potential for iatrogenic
transmission of pathogenic viruses. This paper reviews regulatory
guidance and practical strategies for designing viral clearance
studies. Essential elements for a developmental phase-appropriate viral
clearance package are detailed.
Saturday, 19 September 2015
NDA for first tablet with stomach-activated digital sensor
A Japanese company has filed the first US
FDA application for a drug with an embedded sensor which can tell
doctors if patients have taken their pills.
Read More
Top three reasons to go further with MPI Research
Cardiovascular disease, which includes coronary and
peripheral artery disease, stroke,myocardial infarct and congestive
heart failure, continues to be the leading cause of death worldwide.
Despite the clear potential for impacting human health, drug discovery
and device development in this area has been hampered by challenges in
developing predictive preclinical models for use in evaluating the
efficacy and safety of potential therapeutics. Furthermore, the
extensive range of techniques, models, and assessments relevant for drug
or device development in this space required expertise with these
models and can be time consuming. Read More
Thursday, 4 June 2015
Senior Medical Writer-new Drug Development-Jobnet Network hiring for Leading Healthcare MNC
3,00,000 - 7,00,000 P.A
Need a Medical Writer for Leading Healthcare MNC.
Develop and maintain necessary template .Serve as medical writing lead .
Comply with Client & Company procedure fr completing deliverable .
Update Supervision and team Member about status of Projects .
Need a Medical Writer for Leading Healthcare MNC.
He will be resposible to develop various documents required to clinical drug development , such as re gulatory documents .
Discovery study report, protocol , investgational new drug application
and investigation. Publication ( Abstract, Poster , Manuscripts)
Medical information letter .
candidate should be familiar with chart,table , figure and other display element of the presentation of Pre.Clinical and clinical data
Maintain expert knowledge of US and International regulation ,requirement and guidance associated with clinical regulatory document preparation and submission .Develop and maintain necessary template .Serve as medical writing lead .
Comply with Client & Company procedure fr completing deliverable .
Update Supervision and team Member about status of Projects .
APPLY ONLINE
Medical Writing - Trainee ( Fresher ) Mumbai-Quintiles
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
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 ONLNE
Walkin Interview for Clinical Record Management-Quintiles
- Greetings from Quintiles.
We are conducting Walk-in event on Saturday, 6th of june for Clinical Record Management/ document Management
Exp: 1-4yrs
Job Location :Bangalore
Date: June 6th , Registration Time : 8.00AM - 9.30AM
Venue: Quintiles,
Wing A, Etamin Block, Prestige Tech Park
Sarjapur - Marathalli , Outer Ring Road.
Bangalore: 560103
Land Mark : JP Morgan Stop
Contact Person : Shashikala
please find below the JD .
If available for the interview , please share updated CV with the following details.
Currentc CTC:
Expected CTC:
Notice Period:
Total Exp & Relevant Exp:
Job Title: Clinical Record Management
1. Bachelor's/primary degree from life science ground .
2.Ggood knowledge in clinical research & clinical trial
3. Basic knowledge of applicable research and regulatory requirements, i.e.,ICH GCP and relevant local laws,regulations and guidelines.
4. Effective written and verbal communication skills including good command of English language.
Venue: Quintiles,
Wing A, Etamin Block, Prestige Tech Park
Sarjapur - Marathalli , Outer Ring Road.
Bangalore: 560103
Land Mark : JP Morgan Stop
Contact Person : Shashikala
please find below the JD .
If available for the interview , please share updated CV with the following details.
Currentc CTC:
Expected CTC:
Notice Period:
Total Exp & Relevant Exp:
Job Title: Clinical Record Management
1. Bachelor's/primary degree from life science ground .
2.Ggood knowledge in clinical research & clinical trial
3. Basic knowledge of applicable research and regulatory requirements, i.e.,ICH GCP and relevant local laws,regulations and guidelines.
4. Effective written and verbal communication skills including good command of English language.
Team Manager (pharmacovigilance)-Cognizant
Job Description:-
Verify the metrics and take appropriate action including conducting team review meeting, Liaise with the quality lead, Liaise with the training team if required.
Ensures all the records and documents maintained as per organizational requirements in Sharepoint
People management/team handling experince mandatory
WIllingness to work in rotational shifts.
APPLY ONLINE
Junior Medical Advisor (pharmacovigilance)-Yes Regulatory Healthcare Services Pvt Ltd
Identification of safety-relevant publications in the scientific literature. Provision of scientific input in the course of YES' literature surveillance service.
Creation of response documents in reply to authorities' assessment reports to PSURs and in the course of marketing authorisation application and/or renewal procedures.
Review of literature and review and summary of large safety data sets and presentation of results in draft reports.
Creation, review and submission of ICSRs/CIOMS-I forms.
Single case management with regard to adverse drug reaction reports arising from clinical trials, spontaneous reports or literature, expedited and non-expedited reporting of adverse drug reactions.
Creation of PSURs (Periodic Safety Update Reports) and associated documents such as Addendum to the Clinical Overview.
Creation of various scientific statements focused on individual questions regarding safety-related aspects of drugs (e.g. Risk Management Plans, Signal Detection Reports).
Writing and review of scientific and medical reports.
Preparation and review of Clinical Expert Statements.
Communication with regulatory authorities.
Provision of medical advice to client companies with regard to all pharmacovigilance-focused aspects.
Signal detection.
Safety and benefit-risk evaluations for assigned products.
Management of potential safety issues for assigned products.
APPLY ONLINE
Wednesday, 3 June 2015
Clinical Research Associate - Mumbai-Siro Clinpharm Pvt. Ltd.
- Site Monitoring
To ensure all relevant studies follow SIRO/applicable SOPs, GCP and local regulations.
To do all regulatory/ethics submission as per timelines and to ensure regulatory documents are available, complete and current.
In coordination with the project manager, perform study site selection and qualification visits. Also to participate in/conduct investigators meeting and site initiation visits.
To identify, define, coordinate and conduct site study training.
In coordination with the project manager, provide oversight of all study-related activities.
To perform regular monitoring visits to site
To prepare monitoring reports.
To maintain audit readiness at the site level.
To ensure that the clinical trial supplies are appropriately handled and adequately maintained at the site as per the project requirements.
To ensure site level metrics (i.e. 100% IP accountability, 100% informed consent documentation etc.) are tracked and communicated as appropriate
Issue Resolution
Resolve issues as they affect clinical plan timelines and quality to ensure achievement of goals and objectives at the site level.
Ensure proper escalation of site/project related issues
. Intervention and Coaching
. Teamwork
Liaison with Other Departments
APPLY ONLINE
Pharmovigilance Scientist-Novartis Healthcare Pvt. Ltd.
-
1. Evaluation and QC of Serious Adverse Event / Post Marketing Adverse
Event to ensure accurate and consistent data entry and processing from
source documents, with emphasis on timeliness and quality. 2. Ensure
accurate and consistent coding of medical history, drugs and adverse
event terms. 3. Assess adverse event reports for seriousness, causality
and expectedness as per the Investigator Brochure/Basic Prescribing
Information/US package insert, consulting the Medical Safety Expert
whenever needed. 4. Determine the necessity for follow-up and prepare
follow-up request as needed.
1. Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on timeliness and quality. 2. Ensure accurate and consistent coding of medical history, drugs and adverse event terms. 3. Assess adverse event reports for seriousness, causality and expectedness as per the Investigator Brochure/Basic Prescribing Information/US package insert, consulting the Medical Safety Expert whenever needed. 4. Determine the necessity for follow-up and prepare follow-up request as needed. 5. Work in conjunction with Clinical Safety Associates, Clinical Safety Scientists from other processing sites and Medical Safety Physicians (Pharmacovigilance Leader and Brand Safety Leader) to ensure that reports are accurately evaluated and databased. 6. Triage literature cases for databasing or pass them on to the Team Leader for approval of rejection. 7. Co-author, together with the Medical Safety Physicians, all required regulatory periodic re-ports, collecting, organizing and presenting the available data. 8. Work with external partner groups, e.g. co-licensing partners and ClinicalResearch Organisations to meet joint accountabilities 9. Represent DS&E at internal and external meetings 10. Assist the Medical Safety Physicians with project activities in specific therapeutic areas, compatibly with the timely processing/production of individual case reports and regulatory periodic reports. 11. Assist the Medical Safety Physicians in monitoring the safety profile of product 12. Be involved in development and testing of safety systems/IT applications and in the preparation of relevant manuals. 13. Participate in cross-functional teams on safety matters/DS&E special projects relating to investigational and marketed drugs Impact on the organization: Ensure that Serious Adverse Event / Post Marketing Adverse Event are evaluated accurately and within the required timeframes to meet regulatory requirements Alert the Medical Safety Physicians to potential safety issues.
Desired Candidate Profile
Education-
UG: B.Sc - Nursing
PG:Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate:Doctorate Not Required
PG:Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate:Doctorate Not Required
- Minimum requirements:
Life sciences degree / Nursing background Good knowledge/fluency in English. Knowledge of other languages desirable. Experience in drug safety / Development or closely related areas of responsibility Experience of safety document writing Good negotiation and oral communication skill.
APPLY ONLINE
Walk - In Interview in Quintiles on 6th June 2015
Walkin Interview in Quintiles on 6th June 2015.
Desired Profile:-
Clinical Research Professionals - Looking for candidates with 1 - 7 years of clinical research experience , CRA, CTA, CPC, Research Professionals, Scientist are all welcome.
Clinical Project Co - ordinators - Looking for candidates with 1+ years in clinical research.
Line Managers: Looking for Candidates with 6 + years of experience in supervisory roles in Clinical / Pharma/ Healthcare domain.
Trainers - Looking for Candidates with 6+years of training experience in clinical domain
Date: June 6th , Registration Time : 8.00AM - 9.30AM
Venue: Quintiles,
Wing A, Etamin Block, Prestige Tech Park
Sarjapur - Marathalli , Outer Ring Road.
Bangalore: 560103
Desired Profile:-
Clinical Research Professionals - Looking for candidates with 1 - 7 years of clinical research experience , CRA, CTA, CPC, Research Professionals, Scientist are all welcome.
Clinical Project Co - ordinators - Looking for candidates with 1+ years in clinical research.
Line Managers: Looking for Candidates with 6 + years of experience in supervisory roles in Clinical / Pharma/ Healthcare domain.
Trainers - Looking for Candidates with 6+years of training experience in clinical domain
Date: June 6th , Registration Time : 8.00AM - 9.30AM
Venue: Quintiles,
Wing A, Etamin Block, Prestige Tech Park
Sarjapur - Marathalli , Outer Ring Road.
Bangalore: 560103
Quality Control Specialist- Publications-Cactus Communications
The medical writing team at CACTUS works with multinational
pharmaceutical companies, clinical research organizations, and
researchers worldwide to help them communicate their science. We are
currently looking to add to our team, an experienced QC specialist who
wishes to be part of a world-class delivery team, and work in an
exciting, fast-paced global environment.
As part of his/her key responsibilities, the QC specialist at CACTUS will
As part of his/her key responsibilities, the QC specialist at CACTUS will
- Fact check manuscripts, posters, slide decks, educational material, medical literature, etc, provided by clients for data accuracy
- Check documents (mentioned above) developed by medical writers for scientific data errors by checking the developed material against annotated references, CSRs, other source data
- Check for discrepancy within text, discrepancy between figures/tables, and between text and supplementary material
- Identify missing sources documents and gaps in scientific logic
- Check for grammar, syntax, style, and compliance with style guides, regulatory guidelines, and publishing requirements
- Be responsible for the quality of the documents/projects fact checked/QCed
- Ensure effective communication of QC/fact check findings with the client/medical writers
- Deliver QC reports to the stakeholders, and identify quality trends
- Ensure 100% timely delivery of documents
Desired Candidate Profile
Education-
UG: B.Pharma - Pharmacy, BHM - Hotel Management, B.Sc - Any Specialization
PG:M.Sc - Any Specialization
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
PG:M.Sc - Any Specialization
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
- This position requires:
- Minimum 2 years of experience in the medical writing industry; freshers with substantial knowledge of the publication landscape and with published papers are also eligible
- PhD or Masters degree in Research, or equivalent industry experience
- Ability to work efficiently and independently, multitask, and prioritize
- Excellent attention to detail, and zero tolerance to errors
- Ability to concentrate and work under pressure and meet tight deadlines
- Excellent written and oral communication skills
- Functional with Microsoft Word, Excel, and PowerPoint
- Flexible and adaptable to changing project priorities and work assignments
APPLY ONLINE
Global Medical Affairs Manager role with US Pharma MNC
15,00,000 - 22,50,000 P.A
-
1) Responsible for providing medical and scientific expertise for the
support of EPD products including regulatory and safety documents;
advertising and promotional review; and global medical information.
2) Serves as a conduit and facilitator of communication between Medical Affairs and Commercial, Global PV, Global Regulatory, and affiliate medical departments with respect to assigned brands.
3) Provides training to affiliates and other colleagues on medical information and medical review skills to support their business objectives.
Desired Candidate Profile
Education-
UG: B.Pharma - Pharmacy, MBBS - Medicine
PG:M.Pharma - Pharmacy, M.S/M.D - Any Specialization
Doctorate:Doctorate Not Required, Ph.D - Advertising/Mass Communication, Medicine, Pharmacy, Other Science
PG:M.Pharma - Pharmacy, M.S/M.D - Any Specialization
Doctorate:Doctorate Not Required, Ph.D - Advertising/Mass Communication, Medicine, Pharmacy, Other Science
- 1) Minimum of 4 years of combined licensed clinical practice experience, postgraduate training, and/or postgraduate pharmaceutical industry experience.
2) Strong clinical reasoning skills, with the ability to independently assess and conclude on published and in-house data related to pharmaceutical products and EPDs therapeutic areas
3) Needs to be able to think strategically and demonstrate ability to make effective decisions based on good science and data in compliance with regulatory requirements; can comfortably handle risk assessment and uncertainty.
4) Basic knowledge of industry trends and processes, clinical data, statistical concepts, and regulatory requirements to provide scientific and clinical support of pharmaceutical products.
5) Strong writing skills are required.
6) Successful project management experience required.
APPLY ONLINE
Senior Medical Writer/ Junior Medical Writer (1-4 yrs)-Openings: 3-Digital A Plus Group
-
Develop scientific medical content. meeting international quality
standards. Development of medical e-learning modules, brochures,
e-detailers, websites, apps, MOAs, teasers, manuscripts, articles, TOCs,
Interface with clients on a regular basis.
Desired Candidate Profile
Education-
UG: B.Pharma - Pharmacy, MBBS - Medicine, BDS - Dentistry
PG:Post Graduation Not Required, M.Pharma - Pharmacy
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
PG:Post Graduation Not Required, M.Pharma - Pharmacy
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
-
Min 1 to 4 yrs of experience in pharmaceutical companies in any of the
following functions-medical services/ medico-marketing / regulatory
affairs or in medical writing/ developing/ publishing medical content.
Strong written and verbal communication.
APPLY ONLINE
Thursday, 14 May 2015
Programmer Analyst (walkin Drive on 16 May in Hyderabad)-Theorem Clinical Research India Private Limited
Job Location : Bangalore
We are conducting Walkin Drive on 16 May in Hyderabad
SAS programmer who should be able to produce basic analysis displays and information from the clinical data management database.
All responsibilities from the Programmer position will be performed, in addition to the following:
Handle miscellaneous tasks as assigned by management.
Create SAS datasets of clinical data from clinical databases; create status and efficacy datasets; create project specific macros and
formats; load client data from other platforms and other software packages; prepare data to be sent to clients.
Prepare documentation describing all datasets and variables within, including derived variables, and the project as a whole.
Perform data checks as needed, to ensure integrity and correctness of data displays. Prepare documentation for programs.
Program customized data displays, (including data listings, summary tables and routine graphics) in accordance with approved
statistical analysis plan and shell displays for clinical research studies. Code is to be written using Base SAS programs, SAS procedures,
or standardized macros. Perform data checks as needed to understand structure and content of data.
Act as lead programmer for projects
We are conducting Walkin Drive on 16 May in Hyderabad
SAS programmer who should be able to produce basic analysis displays and information from the clinical data management database.
All responsibilities from the Programmer position will be performed, in addition to the following:
Handle miscellaneous tasks as assigned by management.
Create SAS datasets of clinical data from clinical databases; create status and efficacy datasets; create project specific macros and
formats; load client data from other platforms and other software packages; prepare data to be sent to clients.
Prepare documentation describing all datasets and variables within, including derived variables, and the project as a whole.
Perform data checks as needed, to ensure integrity and correctness of data displays. Prepare documentation for programs.
Program customized data displays, (including data listings, summary tables and routine graphics) in accordance with approved
statistical analysis plan and shell displays for clinical research studies. Code is to be written using Base SAS programs, SAS procedures,
or standardized macros. Perform data checks as needed to understand structure and content of data.
Act as lead programmer for projects
APPLY HERE
Openings for Clinical Data Coordinator-Quintiles-Bengaluru/Bangalore
CTC: 3,00,000 - 5,00,000 P.A
Openings: 10
Openings: 10
We have opening in Clinical Data Management department for
people with various experience level. Experience in Medidata Rave is mandatory.
If interested please mail your resume.
Clinical Research Associate - 1 Opening(s)-Micro Labs Limited
- Job Description
- Monitor (pre-study, initiation, routine, and close-out visits) investigator sites for GCP compliance according to Micro Labs SOPs
- Assist in feasibility process and Perform site facilities inspection
- Negotiate study budgets with investigators
- Obtain, review, and process regulatory and administrative documents from investigator sites
- Prepare project management reports as per SOPs
- Review and approve monitoring trip reports
- Respond to site issue (i.e., non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction)
- Update all relevant tracking system on an ongoing basis
- Escalate any issues that require immediate action to the reporting manager
Mrs.Gayathiri.N
Micro Labs Limited
# 27 Race Course Road KCN Towers Bangalore - 1
BANGALORE,Karnataka,India 560001
APPLY HERE
Clinical Research Associate-MV Hospital for Diabetes (P) Ltd -Chennai
CTC: 1,25,000 - 1,75,000 P.A
- MV Hospital for Diabetes requires Clinicalresearchassociate for Research project.
- To work in the research dept.
- To handle research projects.
- Willing to work for minimum 2 years.
Qualification: BSc / MSc life science
Freshers also can apply
APPLY HERE
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