Drug Safety Scientist Job at Talent Groups, Waltham, MA

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  • Talent Groups
  • Waltham, MA

Job Description

Job Description

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).

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