At Clinogenesis Research Organization, we are dedicated to advancing global healthcare through excellence in clinical research, drug safety, and data management. We pride ourselves on nurturing raw talent and providing a launching pad for the next generation of life sciences professionals.
We are expanding our Drug Safety team and are looking for enthusiastic, detail-oriented Freshers to join us as Pharmacovigilance Associates.
What You Will Do (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).
Who We Are Looking For (Eligibility Criteria):
- Education: B.Sc. / M.Sc. / B.Pharm / M.Pharm / Pharm.D or any graduate in Life Sciences (Biotechnology, Microbiology, Biochemistry, Zoology, etc.).
- Certification: Mandatory certification in Pharmacovigilance / Drug Safety / MedDRA coding.
- Experience: Freshers only (2024 / 2025 / 2026 graduates)
Skills Needed:
- Strong understanding of basic human anatomy, physiology, and pharmacology.
- Excellent written and verbal communication skills in English (crucial for narrative writing).
- High attention to detail and solid analytical thinking.
- Basic proficiency in MS Office (Word, Excel).