Sr. PV Drug Safety Scientist

Duration : 6+ Months

Location : Waltham, MA. Hybrid. 3 days per week onsite

Key Responsibilities :

• Lead safety surveillance and signal evaluation activities in collaboration with safety physicians.
• Manage aggregate safety reports (PADER, PSUR, DSUR) including data analysis, authoring, and quality review.
• Oversee literature monitoring, vendor coordination, and ensure timely safety data updates.
• Prepare materials and data summaries for internal safety and governance meetings.
• Support responses to regulatory or internal safety queries through data analysis and documentation.
• Contribute to safety review of investigational programs, including data monitoring and protocol updates.
• Ensure compliance with global pharmacovigilance regulations and internal safety processes.
• Drive process improvement and maintain consistency across products and teams.

Qualifications :