Senior PV Scientist - Hybrid
Seeking an experienced Senior Pharmacovigilance Scientist to lead safety surveillance and aggregate reporting for marketed and investigational products. This role partners with the Safety Physician for signal detection/evaluation, data analysis, literature monitoring, and regulatory safety documentation (PSUR/PADER/DSUR). Supports clinical trial safety activities, prepares safety materials for governance meetings, and ensures compliance with global PV regulations.
Lead safety surveillance, signal management, and aggregate safety reporting
Perform data analysis and author safety documentation for regulatory submissions
Oversee literature monitoring and vendor deliverables
Support clinical trial safety activities for investigational products
Requirements:
5+ years clinical/pharma experience with 3+ years in PV , strong data interpretation and report authoring skills, experience with MedDRA/Argus, and an advanced degree (PharmD/MD/PhD/MPH/RN/NP).