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.
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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