Cipla Ltd. is hiring a Senior Team Member – PV Operations in Vikhroli, Maharashtra, India. This Pharmacovigilance (PV) job is ideal for MBBS professionals with 2–3 years of experience in drug safety, medical review, case processing, and signal detection.
If you are seeking a Pharmacovigilance medical reviewer job in India, this opportunity offers hands-on exposure to global drug safety compliance, aggregate report review, regulatory intelligence, and QPPV activities.
📍 Job Location
- Vikhroli, Maharashtra, India
Cipla Ltd. is a leading global pharmaceutical company focused on high-quality, affordable medicines. With a strong presence in regulated markets, Cipla’s Pharmacovigilance division ensures global compliance, patient safety, and robust signal detection processes across therapeutic portfolios.
🔬 Key Responsibilities – Pharmacovigilance & Drug Safety
1️⃣ Case Processing & Medical Review
- Perform medical review of Individual Case Safety Reports (ICSRs)
- Assign urgency based on seriousness and listed-ness
- Provide expert comments aligned with global regulatory guidelines
- Conduct post-procedural quality checks (PPQC) within SOP timelines
- Guide teams on MedDRA coding
- Act as point of contact for internal/external PV queries
2️⃣ Aggregate Reports & Safety Surveillance
- Medical review of:
- PBRER
- PSUR
- PADER
- RMP
- Safety Summary Reports (SSR)
- Ensure medical cohesiveness across safety documents
- Support regulatory inspections and audits
3️⃣ Signal Detection & Regulatory Intelligence
- Participate in signal validation and prioritization
- Review signal detection reports
- Present in Drug Safety Review Committee (DSRC) meetings
- Analyze health authority response reports
- Review regulatory intelligence updates
4️⃣ Health Hazard Evaluation (HHE)
- Medical review of product quality complaints
- Risk assessment from patient safety perspective
5️⃣ Training & QPPV Support
- Provide Pharmacovigilance training to employees and partners
- Conduct training on MedDRA updates
- Support QPPV activities for assigned regions
🎓 Eligibility & Qualifications
Minimum Qualification:
- MBBS (Mandatory)
Experience Required:
- 2–3 years as Medical Reviewer in:
- Pharmacovigilance
- Drug Safety Case Processing
- Added advantage:
- Experience in aggregate reports
- Signal detection activities
📊 Role Dimensions
- ~25 complaints/cases reviewed per month
- 10% PPQC of ~300 monthly cases
- ~15 aggregate reports per month
- Signal data review every 6 months
💼 Why Apply for This PV Medical Reviewer Role?
- Exposure to global Pharmacovigilance compliance
- Experience in regulatory inspections and audits
- Opportunity to work on signal detection and risk management
- Strategic interaction with medical writing and labeling teams
- Strong learning curve in regulatory intelligence
📌 Primary Keywords Targeted
Pharmacovigilance job in India, MBBS drug safety job, Medical Reviewer PV role, Cipla PV Operations, Signal Detection job India, PSUR PBRER review job, Regulatory intelligence Pharmacovigilance.
📬 How to Apply
