Meet Life Sciences
Associate Director, Safety Science
Meet Life Sciences, Brisbane, California, United States, 94005
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Job Title:
Associate Director, Safety Science Job Description: We are seeking an experienced
Associate Director, Safety Science
to lead safety signal detection, case review, and aggregate reporting for both investigational and marketed products. This role plays a key part in product safety evaluation across the product lifecycle, ensuring regulatory compliance and contributing to risk management strategies. Key Responsibilities: Perform medical review of pre- and post-marketing individual case safety reports (ICSRs), ensuring accurate MedDRA coding, and proper assessment of seriousness, causality, expectedness, and reportability Collaborate cross-functionally to detect, evaluate, and manage potential safety signals Prepare and contribute to aggregate safety reports (e.g., PBRERs, DSURs, US PADERs, IND Annual Reports) Support development and updates of Risk Management Plans (RMPs) and safety surveillance strategies Participate in Safety Management Teams and interface with clinical teams, CROs, regulatory, and medical affairs Provide medical safety input for key clinical and regulatory documents including protocols, IBs, CSRs, NDAs/BLAs Maintain compliance with safety Data Exchange Agreements when interacting with external partners Timely, high-quality ICSR reviews in Argus Completed signal evaluation forms and safety signal work-ups Aggregate safety reports and RMPs Presentation materials for internal safety review committees Qualifications: Degree in a health science field (BSN, RN, PharmD, MD, DO, or equivalent) Significant experience in pharmacovigilance or drug safety, with strong knowledge of global safety regulations Apply now
to make a direct impact on the safety of therapies that matter. 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 Meet Life Sciences by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for Safety Director roles.
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Associate Director, Safety Science Job Description: We are seeking an experienced
Associate Director, Safety Science
to lead safety signal detection, case review, and aggregate reporting for both investigational and marketed products. This role plays a key part in product safety evaluation across the product lifecycle, ensuring regulatory compliance and contributing to risk management strategies. Key Responsibilities: Perform medical review of pre- and post-marketing individual case safety reports (ICSRs), ensuring accurate MedDRA coding, and proper assessment of seriousness, causality, expectedness, and reportability Collaborate cross-functionally to detect, evaluate, and manage potential safety signals Prepare and contribute to aggregate safety reports (e.g., PBRERs, DSURs, US PADERs, IND Annual Reports) Support development and updates of Risk Management Plans (RMPs) and safety surveillance strategies Participate in Safety Management Teams and interface with clinical teams, CROs, regulatory, and medical affairs Provide medical safety input for key clinical and regulatory documents including protocols, IBs, CSRs, NDAs/BLAs Maintain compliance with safety Data Exchange Agreements when interacting with external partners Timely, high-quality ICSR reviews in Argus Completed signal evaluation forms and safety signal work-ups Aggregate safety reports and RMPs Presentation materials for internal safety review committees Qualifications: Degree in a health science field (BSN, RN, PharmD, MD, DO, or equivalent) Significant experience in pharmacovigilance or drug safety, with strong knowledge of global safety regulations Apply now
to make a direct impact on the safety of therapies that matter. 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 Meet Life Sciences by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for Safety Director roles.
Alameda, CA $172,000.00-$245,000.00 3 days ago Director (JC-482828) - Rail Safety Division
San Francisco, CA $175,000.00-$200,000.00 6 days ago South San Francisco, CA $140,000.00-$180,000.00 1 month ago Associate Director, Food Safety & Quality Assurance
Alameda, CA $160,000.00-$195,000.00 1 week ago South San Francisco, CA $235,144.00-$290,472.00 6 days ago San Francisco, CA $124,400.00-$291,600.00 8 months ago Global Director of Safety, Health, and Environment (HSE)
Alameda, CA $180,000.00-$240,000.00 1 month ago Safety Manager (or Director)- Heavy Civil
North Richmond, CA $130,000.00-$160,000.00 3 hours ago Safety Manager (or Director)- Heavy Civil
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Director, Clinical Quality & Patient Safety
Senior Director of Quality and Patient Safety
San Francisco, CA $144,200.00-$350,000.00 3 months ago South San Francisco, CA $235,144.00-$290,472.00 6 hours ago Head of Waymo Training and Documentation
San Francisco, CA $226,000.00-$286,000.00 3 days ago Senior Medical Director, Patient Safety & Pharmacovigilance
South San Francisco, CA $287,292.00-$354,891.00 6 days ago Executive Medical Director, Head of Safety Science
San Rafael, CA $326,000.00-$440,000.00 3 days ago Senior Director of Engineering, Identity - Safety & Civility
San Mateo, CA $500,210.00-$546,060.00 2 weeks ago Director - Infection Prevention & Control
Oakland, CA $135,200.00-$140,000.00 2 weeks ago South San Francisco, CA $130,000.00-$135,000.00 2 weeks ago Senior Medical Director, Patient Safety & Pharmacovigilance
South San Francisco, CA $287,292.00-$354,891.00 6 hours ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr