Meet Life Sciences
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Base pay range
$270,000.00/yr - $310,000.00/yr Additional compensation types
Annual Bonus, RSUs, and Stock options Title: Director, Patient Safety (MD) Location: Hybrid, 2-3x onsite per week in the Bay Area We are seeking a highly skilled physician to join our client\'s growing biopharmaceutical team as a
Director, Patient/Drug Safety . In this role, you will provide medical expertise and oversight across clinical and post-marketing safety activities. You’ll play a key part in ensuring proactive safety surveillance, regulatory compliance, and high-quality safety deliverables that support both investigational and marketed products. Key Responsibilities
Provide medical review and assessment of individual adverse event (AE) reports from clinical trials, spontaneous sources, literature, and post-marketing experience. Lead aggregate safety data evaluation, including signal detection, trend analyses, and benefit–risk assessments. Contribute to the preparation, authoring, and review of aggregate safety reports (e.g., DSURs, PBRERs/PSURs, RMPs, regulatory safety summaries). Draft and review safety-related sections of clinical study protocols, investigator brochures, informed consent forms, and clinical study reports. Support safety governance activities, including safety review meetings and signal detection committees. Collaborate with pharmacovigilance operations teams and external vendors to ensure quality, compliance, and timely case processing. Author and review responses to regulatory authority safety inquiries (FDA, EMA, MHRA, PMDA, Health Canada, etc.). Serve as a medical representative in health authority interactions, inspections, and audits related to safety. Provide clinical input into risk management strategies, safety surveillance plans, and labeling updates. Partner cross-functionally with Clinical Development, Regulatory, Medical Affairs, and Quality to ensure alignment on safety-related issues. Qualifications
Medical Degree (MD, DO, or equivalent) 5+ years of experience in pharmacovigilance/drug safety within the biopharmaceutical industry, including direct medical review of adverse events. Strong knowledge of global safety regulations and guidelines (FDA, EMA, ICH, GVP, etc.). Hands-on experience in case-level safety assessment, signal detection, aggregate report writing, and risk–benefit evaluation. Proven track record of interacting with U.S. and ex-U.S. health authorities on safety matters. Prior experience authoring and reviewing safety-related regulatory documents. Excellent analytical, communication, and cross-functional collaboration skills. Ability to thrive in a fast-paced, entrepreneurial environment while balancing strategic oversight with hands-on execution. Interested in learning more about the client and role? Apply today! Seniority level
Director Employment type
Full-time Job function
Science, Research, and Analyst 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 about new Safety Director jobs in
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$270,000.00/yr - $310,000.00/yr Additional compensation types
Annual Bonus, RSUs, and Stock options Title: Director, Patient Safety (MD) Location: Hybrid, 2-3x onsite per week in the Bay Area We are seeking a highly skilled physician to join our client\'s growing biopharmaceutical team as a
Director, Patient/Drug Safety . In this role, you will provide medical expertise and oversight across clinical and post-marketing safety activities. You’ll play a key part in ensuring proactive safety surveillance, regulatory compliance, and high-quality safety deliverables that support both investigational and marketed products. Key Responsibilities
Provide medical review and assessment of individual adverse event (AE) reports from clinical trials, spontaneous sources, literature, and post-marketing experience. Lead aggregate safety data evaluation, including signal detection, trend analyses, and benefit–risk assessments. Contribute to the preparation, authoring, and review of aggregate safety reports (e.g., DSURs, PBRERs/PSURs, RMPs, regulatory safety summaries). Draft and review safety-related sections of clinical study protocols, investigator brochures, informed consent forms, and clinical study reports. Support safety governance activities, including safety review meetings and signal detection committees. Collaborate with pharmacovigilance operations teams and external vendors to ensure quality, compliance, and timely case processing. Author and review responses to regulatory authority safety inquiries (FDA, EMA, MHRA, PMDA, Health Canada, etc.). Serve as a medical representative in health authority interactions, inspections, and audits related to safety. Provide clinical input into risk management strategies, safety surveillance plans, and labeling updates. Partner cross-functionally with Clinical Development, Regulatory, Medical Affairs, and Quality to ensure alignment on safety-related issues. Qualifications
Medical Degree (MD, DO, or equivalent) 5+ years of experience in pharmacovigilance/drug safety within the biopharmaceutical industry, including direct medical review of adverse events. Strong knowledge of global safety regulations and guidelines (FDA, EMA, ICH, GVP, etc.). Hands-on experience in case-level safety assessment, signal detection, aggregate report writing, and risk–benefit evaluation. Proven track record of interacting with U.S. and ex-U.S. health authorities on safety matters. Prior experience authoring and reviewing safety-related regulatory documents. Excellent analytical, communication, and cross-functional collaboration skills. Ability to thrive in a fast-paced, entrepreneurial environment while balancing strategic oversight with hands-on execution. Interested in learning more about the client and role? Apply today! Seniority level
Director Employment type
Full-time Job function
Science, Research, and Analyst 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 about new Safety Director jobs in
San Francisco Bay Area . Vice President, Head of United States (U.S.) Medical Affairs Executive Director, Head of U.S. Medical Population Science & Health San Francisco, CA $124,400.00-$291,600.00 10 months ago Executive Director, US Medical Affairs (USMA) Strategy – Liver and Covid Director, Jail Health Care Coordination (0923 Manager II) San Francisco, CA $144,560.00-$184,496.00 6 days ago Director, Jail Health Care Coordination (0923 Manager II) San Francisco, CA $144,560.00-$184,496.00 6 days ago San Francisco, CA $254,900.00-$278,500.00 5 days ago Street Health Manager (0923 Manager II) - Department of Public Health
San Francisco, CA $144,560.00-$184,496.00 1 month ago Director - Infection Prevention & Control
Novato, CA $85,000.00-$95,000.00 2 weeks ago Agricultural Commissioner/Sealer of W & M
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