Drug Safety Manager

Company: GForce Life Sciences
Location: Trenton
Posted on: May 15, 2022

Job Description:

Pharmacovigilance Manager, Aggregate Reports, Pharmaceuticals

Responsibilities
Support roles involved in the creation of Aggregate Safety Reports (ASR)
Facilitate Aggregate Report production activities across CSPV and other organizations for PSUR, RMP updates, DSURs, and other reports as required
Request standard output for ASRs according to project plan timelines
Lead ongoing ASR production meetings

Perform the following project management activities on CSPV projects:
Work with the cross-functional project teams (safety scientists, project leads) to define, capture and track actions, decisions, issues, and risks to the project.
Facilitate safety governance meetings and document/publish discussion, actions and decisions
Capture and track actions, decisions, issues, and risks identified during the safety governance meetings

Education and Experience
5+ years of global aggregate report experience
Extensive knowledge of US, ICH, and EU PV and GCP regulations
Experience in table generation for aggregate reports
Experience with CA Inspections (PV and GCP)
Experience managing vendors
Experience working with Alliance Partners and managing Pharmacovigilance Agreements
Advanced Health Care Professional degree required (MD, PharmD., Nurse Practitioner, Physician Assistant)

Terms & Start
12+ month contract with the ability to extend
Remote - prefer local to NJ for potential onsite meetings
EST work hours
Full time (40hrs/week)
Benefits included - health, dental, vision, 401k

Keywords: GForce Life Sciences, Trenton , Drug Safety Manager, Executive , Trenton, New Jersey