Associate Pharmacovigilance

About Us

At Clinogenesis Research Organization, we are dedicated to advancing global healthcare through excellence in clinical research, drug safety, and data management. We are expanding our Drug Safety team and are looking for enthusiastic, detail-oriented Freshers to join us as Pharmacovigilance Associates.

Key Responsibilities

As a Fresher PV Associate, you will undergo comprehensive training to master drug safety operations. Your daily responsibilities will include:

• ICSR Processing: Review, log, and triage Individual Case Safety Reports (ICSRs) originating from clinical trials, spontaneous reports, and medical literature.
• Data Entry & Triage: Accurately enter adverse event data into global safety databases following strict 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 explaining the chronological sequence of adverse events.
• Quality & Compliance: Ensure all cases are processed within strict regulatory timelines mandated by global authorities (FDA, EMA, CDSCO).

Requirements & Tech Stack

• Education: B.Sc. / M.Sc. / B.Pharm / M.Pharm / Pharm.D or any graduate in Life Sciences (Biotechnology, Microbiology, Biochemistry, Zoology, etc.).
• Graduation Year: 2024, 2025, or 2026 pass-outs with all marks cards cleared.
• Certification: Mandatory certification in Pharmacovigilance / Drug Safety / MedDRA coding.
• Skills Needed:
• 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).