About the job
Join PrimeVigilance as a Senior Pharmacovigilance Officer, where you will play a critical role within our independent case processing team. Our PV Officers are entrusted with a variety of pharmacovigilance services, demonstrating full accountability in all aspects of case processing.
This position offers you the chance to collaborate with diverse teams, ranging from small clinical trial groups to extensive generic post-marketing teams. We are on the lookout for proactive, skilled, and motivated professionals who consistently strive to exceed set objectives.
The ideal candidate should possess a healthcare-related degree (Pharmacy, MD, Nursing, etc.) with proven experience in case processing.
As part of a project team, you will conduct and support pharmacovigilance activities on behalf of PrimeVigilance. Expect to achieve and maintain a high-performance level within three months of joining an ICSR team, following a thorough onboarding process.
Your responsibilities will include:
Processing Individual Case Safety Reports from various sources (post-marketing and clinical trials, including device and combination products) while ensuring compliance with relevant regulations, procedures, and client-specific requirements and timelines. You will be expected to oversee all workflow cycle steps, excluding Medical Review.
Managing SAE/SUSAR submissions independently, including unblinding and clinical trial reconciliations.
Preparing database outputs for periodic reporting (PBRER, DSUR, PADER, etc.).
Mentoring and training junior team members, optimizing procedures, and contributing to departmental development.

