Associate Pharmacovigilance

About the Role

Clinogenesis Research Organization is expanding its Drug Safety team and is seeking enthusiastic, detail-oriented Freshers to join as Pharmacovigilance Associates. This is an entry-level, full-time, remote position.

Key Responsibilities

As a Fresher PV Associate, you will receive comprehensive training covering:

• ICSR Processing: Review, log, and triage Individual Case Safety Reports (ICSRs) from clinical trials, spontaneous reports, and medical literature.
• Data Entry & Triage: Accurately enter adverse event data into global safety databases following standard operating procedures (SOPs).
• Medical Coding: Learn and apply MedDRA (Medical Dictionary for Regulatory Activities) and WHO Drug dictionaries for coding adverse events and medications.
• Narrative Writing: Draft clear, concise, and medically accurate case narratives detailing the chronological sequence of adverse events.
• Quality & Compliance: Ensure all cases are processed within regulatory timelines mandated by global authorities (e.g., FDA, EMA, CDSCO).

Qualifications

• Education: B.Sc. / M.Sc. / B.Pharm / M.Pharm / Pharm.D or any graduate in Life Sciences (e.g., Biotechnology, Microbiology, Biochemistry, Zoology).
• Graduation Year: 2024, 2025, or 2026 pass-outs with all marks cards cleared.
• Certification: Mandatory certification in Pharmacovigilance / Drug Safety / MedDRA coding.
• Skills:
• Strong understanding of basic human anatomy, physiology, and pharmacology.
• Excellent written and verbal communication skills in English.
• High attention to detail and strong analytical thinking.
• Basic proficiency in MS Office (Word, Excel).