Job Description

1 day ago Be among the first 25 applicants Direct message the job poster from Tucker Parker Smith Group (TPS Group) 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 Referrals increase your chances of interviewing at Tucker Parker Smith Group (TPS Group) by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified about new Director Quality Compliance jobs in Brisbane, CA . South San Francisco, CA $80.00-$93.00 6 hours ago Union City, CA $213,282.00-$355,908.00 4 days ago SR Director, Quality Assurance (GCP/GLP) South San Francisco, CA $300,000.00-$330,000.00 3 weeks ago Sr. Director, Global QA Clinical Quality Assurance South San Francisco, CA $255,000.00-$306,000.00 3 weeks ago Director, Good Clinical Practice Quality Assurance South San Francisco, CA $192,780.00-$238,140.00 2 days ago Director, Pharmacovigilance Quality Assurance Redwood City, CA $218,400.00-$256,900.00 2 weeks ago South San Francisco, CA $180,000.00-$225,000.00 2 months ago Senior Director, GCP/GVP Quality Assurance San Francisco, CA $260,000.00-$275,000.00 5 days ago Associate Director, GMP Quality Assurance San Francisco, CA $180,000.00-$195,000.00 2 weeks ago Hercules, CA $199,400.00-$274,100.00 2 weeks ago Director, Clinical Compliance and Documentation Regional Director Lab Compliance & Risk Management Senior Director, Global Regulatory Affairs Foster City, CA $270,000.00-$285,000.00 2 weeks ago Director - Clinical Srvcs, Cont. Quality Improvement - 90 Director, Good Clinical Practice Quality Assurance South San Francisco, CA $192,780.00-$238,140.00 3 weeks ago Foster City, CA $210,000.00-$225,000.00 2 weeks ago Associate Director, Process Development and Documentation, Clinical Quality Assurance Redwood City, CA $183,300.00-$215,600.00 2 weeks ago San Pablo, CA $93,900.00-$156,400.00 1 week ago San Francisco, CA $144,066.00-$190,000.00 2 weeks ago San Francisco, CA $135,000.00-$202,500.00 1 month ago Lafayette, CA $126,000.00-$144,900.00 1 day ago Director - Infection Prevention & Control San Francisco, CA $115,500.00-$173,300.00 1 month ago Associate Project Director - Mass Transit, for COWI in North America San Francisco, CA $172,000.00-$262,000.00 6 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

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