Senior Pharmacovigilance Specialist
Clarivate
Full time- 5+ years
- Not Disclosed
- Noida, India
- Post Date: Apr 30, 2024
- End Date: Jun 30, 2024
- 5+ years
- Not Disclosed
- Noida, India
- Post Date:Apr 30, 2024
- End Date: Jun 30, 2024
Skills:
- pharma
- Quality control
- Management
Job Description:
Responsibilities
- Critically analyses large numbers of articles from biomedical published literature and internal drug safety alerts and identifies individual case safety reports (ICSRs) as well as other potential safety-relevant information impacting the risk-benefit and/or safety profile of customer’s products, as per applicable regulatory requirements and standard operating procedures.
- Write brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article.
- Demonstrates understanding of client’s drugs labels and uses that knowledge effectively when performing the safety assessments.
- Completes drug safety reviewing of each biomedical literature batch in a timely, thorough, and accurate manner in accordance with client’s standards of timeliness and quality.
- Uses drug safety system to track all actions and assessments in an audit-ready reference history.
- Selects articles specific to client’s interest for inclusion in client's product literature database per guidelines.
- Writes accurate, detailed, and complete abstracts of selected articles using good judgement regarding the level of detail required and excellent organization, grammar, and syntax.
- Extracts key points of articles and creates comprehensive and detailed indexes of the abstract contents to ensure precise and complete retrieval of literature from client’s database.
- Ensures timely completion of indexing and abstracting of articles for assigned drugs in accordance with regulatory submission deadlines.
Qualification & Experience
- Master’s Degree in life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.)
- At least 5 years of experience reviewing biomedical literature for adverse event reporting OR equivalent combination of education and experience (i.e., an information science degree with at least 5 year of relevant working knowledge of supporting drug and patient safety)
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Salary
Not Disclosed
-
Role
Specialist
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Area of Practice
- Pharmacology/ Pharmacovigilance
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Experience
5+ years
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