Job Post: Pharmacovigilance Specialist
Job Description:
Position Summary: The pharmacovigilance specialist plays a vital role in monitoring biomedical literature, assessing adverse events, and ensuring compliance with pharmacovigilance regulations. Utilizing in-depth scientific knowledge, the specialist contributes to the identification and reporting of safety-related information affecting the risk-benefit profile of client products.
Duties and Responsibilities:
- Analyze biomedical literature for adverse event reporting and identify individual case safety reports (ICSRs).
- Write concise narratives summarizing ICSR criteria and safety-relevant information.
- Utilize knowledge of client’s drug labels for effective safety assessments.
- Complete drug safety reviews in a timely and accurate manner, adhering to quality standards.
- Maintain an audit-ready history using the drug safety system for tracking actions.
- Select and include articles of client interest in the product literature database.
- Write accurate abstracts with attention to detail and excellent organization.
- Extract key points, creating comprehensive indexes for precise literature retrieval.
- Ensure timely completion of indexing and abstracting for regulatory submissions.
- Stay informed about new drugs, therapeutic categories, and changes in biomedical terminology.
- Participate in additional duties such as searches and terminology maintenance.
Candidate Profile:
- Master’s Degree in life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
- Dentistry/physiotherapy/Nursing degree with hospital exposure is advantageous.
- 2-4 years of experience in biomedical literature review for adverse event reporting.
- Relevant experience in drug safety/pharmacovigilance is desirable.
- Strong analytical ability and writing skills for concise summaries.
- Working knowledge of biomedical terminology, drugs, and therapeutic areas.
Skills:
- Excellent English language skills (comprehension, speaking, reading, and writing).
- Proficiency in biomedical terminology, drugs, and therapeutic areas.
- Experience with commercial and client-specific biomedical literature databases.
- Flexibility and adaptability to changing client needs.
- Ability to work effectively, independently, and collaboratively.
- Basic computer literacy.
Additional Information:
- Experience: 2-4 years
- Qualification: Master’s Degree in life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.)
- Location: Noida, UP
- Industry Type: Pharma / Healthcare / Clinical research
- End Date: 30th January 2024
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