Pharmacovigilance Specialist
📍 Location: Karnataka, India
🔍 Industry: Life Sciences & Healthcare
🌍 Work Mode: Hybrid
📌 Job ID: JREQ131112
📅 Posted Date: March 3, 2025
About the Role
As a Pharmacovigilance Specialist, you will be responsible for monitoring biomedical literature to identify adverse events, ensuring regulatory compliance, and contributing to drug safety assessments. This role requires expertise in medical terminology, pharmacovigilance regulations, and scientific writing to support comprehensive drug safety reporting.
Who You Are
Education & Experience:
✔ Master’s degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
✔ A degree in Dentistry, Physiotherapy, or Nursing with hospital-based patient exposure is advantageous.
✔ Minimum 4 years of experience reviewing biomedical literature for adverse event reporting.
✔ OR an equivalent combination of education and experience (e.g., an information science degree with at least 4 years of experience in drug safety and patient care).
✔ Related experience in pharmacovigilance or drug safety is desirable.
Key Skills & Competencies:
✅ Strong analytical ability to evaluate and summarize key findings from biomedical literature and case reports.
✅ Experience in indexing abstracts and providing constructive feedback to screeners on adverse event (AE) reporting.
✅ At least 4 years of scientific writing experience, ensuring clarity, accuracy, and precision.
✅ Working knowledge of biomedical terminology, drugs, and therapeutic areas.
✅ Familiarity with commercial and client-specific biomedical literature databases.
💡 Preferred Qualifications (Nice to Have):
Certification from a professional medical writing association.
Experience in scientific/medical writing.
Prior exposure to pharmacovigilance literature review processes.
Key Responsibilities
🔹 Pharmacovigilance & Literature Monitoring:
Conduct critical analysis of biomedical literature and internal drug safety alerts to identify Individual Case Safety Reports (ICSRs) and other safety-relevant information.
Evaluate articles to assess their impact on the risk-benefit and safety profile of pharmaceutical products.
Provide feedback to primary screeners to ensure accurate adverse event (AE) reporting.
🔹 Scientific Writing & Reporting:
Develop concise narratives summarizing ICSR criteria and key safety-related information.
Write detailed abstracts with proper grammar, structure, and scientific accuracy.
Maintain awareness of new drugs, therapeutic areas, and emerging biomedical terminology.
🔹 Compliance & Data Management:
Ensure timely and high-quality drug safety reviews as per client and regulatory standards.
Use drug safety systems to track decisions and maintain an audit-ready reference history.
Select and categorize articles for inclusion in the client’s product literature database.
🔹 Collaboration & Continuous Learning:
Work closely with cross-functional pharmacovigilance teams to enhance drug safety monitoring.
Participate in additional tasks such as literature searches and terminology maintenance based on business needs.
About the Team
The PV Literature Team is a dynamic, collaborative environment supporting multiple clients across therapeutic areas. Team members receive personalized training, gain exposure to various pharmacovigilance processes, and have opportunities to contribute to regulatory updates and drug safety enhancements.
Work Schedule & Employment Type
📅 Full-time | Permanent
⏰ Monday to Friday, 11 AM – 8 PM IST
Why Join Us?
🌟 Be part of a global leader in pharmacovigilance and drug safety.
📈 Gain hands-on experience in literature-based pharmacovigilance assessments.
🤝 Work in a collaborative and supportive team.
📚 Access ongoing training and career growth opportunities.
💡 At Clarivate, we are committed to fostering diversity, inclusion, and equal employment opportunities. We adhere to all applicable laws and regulations to ensure a fair and inclusive hiring process.
📩 Ready to take your career to the next level? Apply today and make a meaningful impact in the field of pharmacovigilance! 🚀
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