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. 

 

APPLY HERE

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.

APPLY HERE