Associate Director Safety Science

Associate Director, Safety Science

W2 Contract

Salary Range: $251,700 - $272,500 per year

Location: Novato, CA - Hybrid Role

Job Summary

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.

Duties And Responsibilities

• Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving our 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 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 the 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.
  
  

Requirements And Qualifications

• BSN, RN, PharmD, MD, DO, or equivalent
• ICSR reviews in the 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.
  
  

Desired Skills And Experience

Signal detection, aggregate safety reports, ICSR review, MedDRA coding, seriousness assessment, expectedness assessment, causality assessment, regulatory reporting, medical review, pre-marketing safety data, post-marketing safety data, safety surveillance, risk management plans, expedited reports, 15-day Alert Report, SUSAR, PSUR, PBRER, US PADER, Annual Safety Report, DSUR, IND Annual Report, Safety Management Team participation, cross-functional collaboration, clinical operations liaison, medical affairs liaison, biostatistics liaison, regulatory affairs liaison, CRO management, Data Monitoring Committee interface, product labeling, RMP preparation, investigator brochures, protocol safety sections, informed consent forms, statistical analysis plans, clinical study reports, NDA submissions, BLA submissions, CTD submissions, safety documentation, Data Exchange Agreements, business partner interface, Argus safety database, signal evaluation, signal issue work-ups, Product Safety Committee, BSN, RN, PharmD, MD, DO, healthcare degree, pharmaceutical safety, drug safety, pharmacovigilance

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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