About this opportunity
Tucker Parker Smith Group (TPS Group) lists this Associate Director opportunity in brisbane, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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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 Associate 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
Seniority level
Seniority level
Director
Employment type
Employment type
Contract
Job function
Job function
Science
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
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Worksite address
brisbane, CA, 94005, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.