Drug Safety Scientist (Waltham)

Senior Pharmacovigilance (PV) Scientist

Pay Rate : $73 / hour

Reports to : Senior Director of Drug Safety and Pharmacovigilance (DSPV)

Position Summary

The Senior PV Scientist plays a pivotal role in medical analytics and safety coordination for both marketed and investigational products. This position partners closely with the Safety MD / Medical Monitor and cross-functional teams to ensure high-quality safety data analysis, signal detection, and regulatory reporting. The role demands strong leadership, independent initiative, and a deep understanding of regulatory compliance and clinical safety processes.

Key Responsibilities

For Marketed Products :

• Coordinate and document safety surveillance activities with the safety physician
• Lead aggregate safety report development (PSUR, PADER, DSUR), including vendor oversight, data analysis, and quality control
• Manage literature review plans and provide feedback to vendors
• Prepare materials for routine and ad hoc Safety Governance meetings
• Respond to ad hoc safety queries (e.g., health authority requests, NISS, health hazard evaluations)
• Represent safety in cross-functional product meetings

For Investigational Products :

General Duties :

Qualifications

Education