Associate Pharmacovigilance Specialist
📍 Location: Karnataka, India
🔍 Industry: Life Sciences & Healthcare
🌍 Work Mode: Hybrid
📌 Job ID: JREQ131104
📅 Posted Date: March 3, 2025
About the Role
As an Associate Pharmacovigilance Specialist, you will play a vital role in ensuring drug safety by conducting biomedical literature monitoring, assessing adverse event reports, and indexing key findings. This position requires a strong understanding of scientific and medical terminology, pharmaceutical regulations, and pharmacovigilance principles.
Who You Are
Education & Experience:
✔ Master’s degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
✔ Alternatively, a degree in Dentistry, Physiotherapy, or Nursing with hospital-based patient exposure is a plus.
✔ 1-2 years of experience in biomedical literature review for adverse event reporting OR an equivalent combination of education and experience (e.g., an information science degree with at least 1 year of relevant knowledge in drug safety and patient care).
Key Skills & Competencies:
✅ Strong analytical skills to summarize key insights from biomedical case reports, studies, and relevant publications.
✅ At least 1 year of experience in scientific writing, ensuring accuracy, clarity, and conciseness.
✅ Solid understanding of biomedical terminology, drug safety, and therapeutic areas.
✅ Proficiency in English (reading, writing, speaking, and comprehension).
✅ Familiarity with commercial and client-specific biomedical literature databases.
✅ Basic computer literacy and experience working with database management tools.
💡 Preferred Qualifications (Nice to Have):
Certification from a professional medical writing association.
Experience in medical/scientific writing.
Prior exposure to pharmacovigilance literature review processes.
Key Responsibilities
🔹 Literature Review & Adverse Event Reporting:
Analyze biomedical literature and internal safety alerts to identify Individual Case Safety Reports (ICSRs) and other critical safety-related information.
Evaluate articles for relevance to pharmacovigilance and risk-benefit assessment in accordance with regulatory standards.
🔹 Content Development & Scientific Writing:
Prepare clear and concise narratives summarizing ICSR criteria and key safety findings from literature sources.
Develop accurate and structured abstracts with appropriate grammar, organization, and syntax.
Maintain awareness of new drugs, therapeutic areas, and evolving biomedical terminology.
🔹 Regulatory & Compliance Support:
Ensure timely and accurate literature indexing and abstracting to meet regulatory submission deadlines.
Select relevant articles for inclusion in the client’s product literature database, adhering to specific guidelines.
Track assessments and decisions in the drug safety system for audit readiness.
🔹 Collaboration & Continuous Learning:
Engage with the Pharmacovigilance (PV) Literature team, supporting multiple clients across diverse therapeutic areas.
Participate in internal training and stay updated on the latest pharmacovigilance regulations and practices.
About the Team
The PV Literature Team provides a collaborative and supportive work environment, with personalized training and opportunities to explore various aspects of pharmacovigilance. Team members work across multiple therapeutic areas, offering exposure to diverse projects and regulatory frameworks.
Work Schedule & Employment Type
📅 Full-time | Permanent
⏰ Monday to Friday, 11 AM – 8 PM IST
Why Join Us?
🌟 Be part of a globally recognized organization in pharmacovigilance.
📈 Gain expertise in literature-based drug safety assessments.
🤝 Work in a dynamic, team-oriented environment.
📚 Access ongoing training and career growth opportunities.
💡 At Clarivate, we are committed to diversity, inclusion, and equal employment opportunities. We ensure a fair and inclusive hiring process, adhering to all applicable laws and regulations.
📩 Apply today and make an impact in the world of drug safety and pharmacovigilance!
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