Pharmacovigilance, Drug Safety & Regulatory Affairs Roles
🏢 About Cencora
Cencora (via PharmaLex India) is a global healthcare and pharmaceutical services organization specializing in pharmacovigilance, regulatory affairs, and drug safety operations. The company works with leading pharmaceutical clients worldwide, offering strong exposure to global regulatory frameworks and clinical safety systems.
💊 Senior Specialist – Pharmacovigilance (Literature & ICSR)
- Literature screening & Medical Literature Monitoring (MLM)
- ICSR case processing & data entry
- CIOMS / MedWatch / XML report preparation
- Duplicate checks & case validation
- Client communication & coordination
Experience: 2+ Years | Location: Noida
📊 Assistant Manager – PV Quality & QMS
- CAPA management (RCA, Fishbone)
- PV QMS compliance (ICH, GVP, FDA)
- Audit readiness & inspection support
- Compliance dashboards & metrics tracking
- Trend analysis & risk mitigation
Location: Noida
🧑⚕️ Manager – Drug Safety Physician
- PSUR, DSUR, RMP writing
- Medical review & benefit-risk evaluation
- Health authority communication
- Safety strategy development
Qualification: MBBS / MD | Experience: 5–7+ Years
📈 Senior Specialist – PV Epidemiology & Risk Management
- Signal detection & EVDAS screening
- Aggregate reports (PSUR, DSUR, PADER)
- Risk Management Plans (RMP)
- Signal assessment & regulatory communication
Location: Noida / Mumbai
📑 Senior Manager – Regulatory Affairs
- Regulatory submissions & lifecycle management
- Marketing authorization strategy
- Health authority interactions
- Project leadership & team management
Location: Thane | Experience: 12+ Years
🧾 Medical Reviewer – Case Processing
- Medical review of ICSRs
- Causality assessment & narrative review
- MedDRA validation & signal detection support
- Mentoring PV teams
Qualification: MBBS | Experience: 8+ Years
🎓 Eligibility
- B.Pharm / M.Pharm / Pharm.D / MSc Life Sciences
- MBBS / MD (for medical roles)
- Knowledge of ICSR, MedDRA, GVP, regulatory guidelines
⭐ Salary Range
- ₹6 LPA – ₹45 LPA (Role-based)
🎯 Interview Preparation Tips
- Revise ICSR workflow & MedDRA coding
- Understand PSUR, DSUR & RMP concepts
- Study ICH-GCP & EU GVP guidelines
- Learn CAPA & QMS basics
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