Job Description

Director, Safety Science

Location: Brisbane, CA

Department: Pharmacovigilance / Drug Safety

Reports To: Director or Senior Director, Safety Science

12 Month Assignment (Potential to Extend)

Pay Rate: $130/hr.

On behalf of our client a leading pharmaceutical company specialized in therapeutics for patients dealing with life threatening rare genetic diseases. The Director of Safety Science is responsible for the medical review and analysis of safety data for the company’s products. This includes reviewing individual case safety reports (ICSRs), detecting and evaluating safety signals, preparing safety documents and aggregate reports, and working cross-functionally to support regulatory submissions and risk management activities.

Key Responsibilities:

• Conduct thorough medical review of both pre- and post-marketing ICSRs.
• Ensure accuracy in MedDRA coding and proper assessment of seriousness, expectedness, causality, and regulatory requirements.
• Identify, evaluate, and track safety signals in collaboration with Clinical Science, Medical Affairs, and other stakeholders.
• Complete quarterly signal evaluations and detailed signal work-ups.
• Contribute to the creation of key regulatory documents including: 15-day Alert Reports, SUSARs, PSURs (PBRER format), PADERs, DSURs, IND Annual Reports.
• Serve as a member of the Safety Management Team.
• Partner with Clinical Operations, Biostatistics, Regulatory Affairs, Medical Affairs, CROs, and Data Monitoring Committees.
• Prepare and present slide decks for internal safety review meetings.
• Assist in the preparation and review of: Investigator brochures, Clinical study protocols, Informed consent forms, Statistical analysis plans, Clinical study reports, NDA/BLA/CTD submissions, Product labeling and Risk Management Plans (RMPs).
• Work with external partners under safety data exchange agreements.
• Ensure adherence to regulatory guidelines and internal SOPs.

Required Skills & Experience:

• Strong knowledge of safety surveillance and regulatory reporting
• Experience with safety databases (e.g., Argus)
• Familiarity with global safety regulations and MedDRA coding
• Ability to work across functional teams and communicate complex data clearly

Preferred Qualifications:

• Advanced degree (MD, PharmD, PhD) in medicine, pharmacy, or life sciences
• Experience in pharmacovigilance or drug safety in the biotech or pharmaceutical industry
• Proficiency in statistical analysis and safety data interpretation

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