Sr. PV Drug Safety Scientist (Waltham)

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 :

5+ years in clinical, scientific, or pharmaceutical roles with 3+ years in pharmacovigilance.

Strong analytical, communication, and project management skills with expertise in safety data and reporting tools.