Are you passionate about ensuring patient safety and advancing drug development through rigorous pharmacovigilance practices?
ProPharma, a global leader in life sciences consulting, is hiring a Pharmacovigilance (PV) Safety Scientist – Benefit Risk in India. This full-time opportunity is ideal for professionals with 2+ years of PV experience who want to grow in aggregate reporting, signal detection, and global regulatory compliance.
About ProPharma
For over two decades, ProPharma has empowered pharmaceutical, biotech, and medical device organizations worldwide. The company’s advise-build-operate model supports clients across the entire product lifecycle — from clinical research and regulatory science to post-marketing safety and quality compliance.
Key Responsibilities
As a Pharmacovigilance Safety Scientist, you will play a critical role in maintaining patient safety by managing benefit-risk evaluations and authoring global safety reports. Your core duties will include:
- Authoring aggregate reports (PSURs, PBRERs, DSURs, PADERs, Annual Reports).
- Preparing and updating Risk Management Plans (RMPs) and Signal Management Reports.
- Conducting literature searches and validity checks for safety data.
- Extracting and validating safety data (RSI, Sales, RMPs, Signals).
- Managing Line Listings (LL) and reconciling process trackers.
- Supporting ad-hoc pharmacovigilance activities and ensuring deliverables meet global regulatory standards.
- Analyzing medical data to prepare concise and compliant safety summaries.
Required Qualifications
- Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, or a related health discipline.
- Experience: Minimum 2 years in Pharmacovigilance, especially in aggregate reporting, signal detection, or medical writing.
- Strong understanding of ICH-GCP, EMA, FDA PV regulations.
- Excellent analytical, writing, and data interpretation skills.
- Proficiency in MS Office Suite and web-based pharmacovigilance tools.
Why Join ProPharma
- Work in a global pharmacovigilance environment with exposure to leading life sciences clients.
- Collaborate with experts committed to patient safety and regulatory excellence.
- Develop your expertise in aggregate report authoring and signal management.
- Inclusive culture fostering diversity, innovation, and career growth.
- Competitive salary and benefits aligned with global standards.
How to Apply
