A leading service-based CRO is hiring a Pharmacovigilance Safety Scientist in Bangalore (Onsite/Hybrid). This opportunity is ideal for experienced professionals in pharmacovigilance aggregate reporting, signal detection, and benefit-risk evaluation who are looking to grow in global regulatory environments.
With increasing regulatory scrutiny across FDA, EMA, and other global health authorities, demand for skilled PV Safety Scientists is rising in India’s clinical research and drug safety sector.
🔬 Role Overview – Pharmacovigilance Safety Scientist
The Pharmacovigilance Safety Scientist will support the Benefit-Risk group and manage key pharmacovigilance activities, ensuring regulatory-compliant deliverables within timelines. This role requires strong expertise in aggregate safety report writing, literature screening, and signal management.
Work Model: Onsite / Hybrid
Location: Bangalore
Experience Required: 2+ Years in Pharmacovigilance
📌 Key Responsibilities
1️⃣ Aggregate Safety Report Authoring
- PSURs / PBRERs
- PADERs / Annual Reports
- DSUR
- ACO submissions
- Risk Management Plans (RMPs)
2️⃣ Signal & Safety Activities
- Authoring Signal Management Reports
- Literature search & validity assessment
- Data extraction and validation (RSI, sales data, previous reports)
- Generation of Line Listings from safety database
3️⃣ Regulatory Compliance & Documentation
- Ensuring compliance with ICH-GCP, FDA, EMA regulations
- Reconciliation of safety trackers
- Supporting SOP/WI authoring
- Identifying deviations and CAPAs
- Delivering client-ready regulatory documents within timelines
🎯 Required Qualifications
Educational Qualification:
- Bachelor’s or Master’s degree in:
- Pharmacy (B.Pharm / M.Pharm)
- Nursing
- Life Sciences
- Other health-related disciplines
Experience:
- Minimum 2+ years in Pharmacovigilance
- Hands-on experience in:
- Aggregate report writing
- Literature screening
- Signal detection
- Regulatory submissions
🧠 Essential Skills
- Strong analytical and data interpretation skills
- Excellent medical writing ability
- Experience working with large safety datasets
- Knowledge of global PV regulations
- Ability to write concise and unambiguous medical content
- Strong MS Office and database proficiency
- Experience in client-facing discussions and metrics compilation
🌍 Why Consider This Pharmacovigilance Role?
✔ Exposure to global regulatory frameworks
✔ Work in a structured benefit-risk environment
✔ Opportunity to grow in aggregate reporting specialization
✔ Hybrid work flexibility
✔ Involvement in high-priority regulatory submissions
For professionals aiming to advance in Drug Safety, PV Medical Writing, and Regulatory Safety Strategy, this is a strong career move.
📩 How to Apply
