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Associate Director Safety Science

Brisbane, CA 94005

Posted: 04/17/2025 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 619021 Is job remote?: No Country: United States

Job Description


Description

The Associate Director Safety Science performs signal detection activities, prepares aggregate safety reports, reviews ICSRs, and works with cross-functional team to evaluate safety signals. 


Scope
  • Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving company products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting.
  • Assist in follow-up of important ICSRs to ensure relevant information is sought.
  • Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable functional specialists to identify, evaluate and manage safety signals.
  • Participate in the development development of safety surveillance and risk management plans for drug development programs.
  • Contribute to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR (PBRER format), US PADER, Annual Safety Report, DSUR, IND Annual Report).
  • Serve on Safety Management Team and liaise with clinical study/project teams, Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees and other entities as needed.
  • Participate in the preparation and revision of company product labeling and RMP as appropriate.
  • Assist with preparation and review safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other safety documents.
  • Interface with business partners as needed in accordance with applicable safety Data Exchange Agreements.

Deliverable (please have experience with)
  • ICSR reviews in Argus safety database.
  • Completed quarterly signal evaluation forms.
  • Completed signal issue work-ups.
  • Completed aggregate reports.
  • Risk Management Plans.
  • Slide decks for Safety Management Team/Product Safety Committee meetings.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.