The Senior Drug Safety Operations Manager provides senior-level, hands-on operational leadership and oversight for postmarketing and clinical pharmacovigilance activities. The role is accountable for high-quality review and compliant handling of individual case safety reports (ICSRs), effective oversight of outsourced pharmacovigilance services, safety-data reconciliation, regulatory reporting compliance, and safety activities supporting Risk Evaluation and Mitigation Strategy (REMS) and other postmarketing programs.
The incumbent serves as a subject-matter resource for case management and PV operations, develops and implements scalable PV processes, and leads PV inspection-readiness activities using a risk-based approach. The role partners closely with Drug Safety physicians, Regulatory Affairs, Quality, Clinical Development, Medical Affairs, REMS stakeholders, Information Technology, business partners, and external vendors to support marketed and investigational products.
Responsibilities
- Perform hands-on review and quality assessment of clinical-trial and postmarketing ICSRs from spontaneous, solicited, literature, partner, specialty pharmacy, patient support, medical information, product complaint, REMS, digital, and other relevant sources.
- Assess case validity, Day 0, seriousness, expectedness, causality, reportability, MedDRA coding, follow-up needs, and overall case quality.
- Develop/review clear case narratives and company comments, escalating cases requiring medical judgment or Safety Physician input.
- Ensure appropriate coding, follow-up, and handling of special situations, including pregnancy, medication errors, overdose, misuse/abuse, off-label use, lack of efficacy, and product quality complaints with AEs.
- Review and approve ICSRs before submission or partner exchange and manage complex case activities, including duplicates, linking, nullification, upgrades/downgrades, follow-ups, and transfers.
- Author and maintain Safety Management Plans, participate in study team meetings, and perform SAE reconciliation to ensure accurate and compliant safety data.
- Monitor reporting and exchange timelines, submission status, failures, and overdue items; escalate and document compliance issues through resolution. Provide accurate safety database outputs, listings, and case-level analyses for aggregate reports, health-authority responses, inspections, audits, and other regulatory deliverables, while maintaining inspection-ready evidence of reviews, decisions, escalations, and oversight activities.
- Provide risk-based oversight of global PV vendors and service providers across safety intake, processing, medical review, submission, literature, and reconciliation.
- Monitor vendor performance, compliance, quality, deviations, CAPAs, training, and trends; drive governance actions to closure.
- Support vendor qualification, onboarding, training, change management, business continuity, audits, performance reviews, and PV/Safety Data Exchange Agreements.
- Support oversight of the global safety database, including workflows, access, validated changes, data outputs, testing, migration, and system/process implementation.
- Coordinate safety-data reconciliation across internal and external sources and resolve missing cases, duplicates, mismatches, and transfer failures.
- Support REMS and postmarketing PV activities, including AE collection, processing, reconciliation, vendor guidance, deviations/CAPAs, and regulatory safety reporting.
- Develop and maintain scalable PV procedures, work instructions, tools, conventions, and training materials.
- Investigate and trend deviations and quality issues; support CAPAs and effectiveness checks.
- Lead PV inspection readiness and support audits and inspections, including preparation, evidence coordination, responses, and remediation.
- Drive process improvement, standardization, automation, workload planning, and implementation of regulatory or industry changes.
- Serve as a senior PV operations SME across ICSR management, vendor oversight, reconciliation, and compliance; provide cross-functional leadership, risk communication, coaching, and work direction.
- Support PV activities for REMS and other postmarketing programs, including AE collection, processing, follow-up, reconciliation, vendor guidance and training, review of REMS procedures and materials, investigation of deviations and CAPAs, and preparation and quality review of safety data supporting REMS Assessment Reports and FDA responses.
Qualifications
- Bachelor's degree in life sciences, pharmacy, nursing, medicine, or a related healthcare or scientific discipline required; advanced degree or relevant professional certification preferred.
- Minimum 8 years of progressive pharmaceutical, biotechnology, contract research, or related experience, including at least 5 years of direct pharmacovigilance operations experience; equivalent combinations of education and relevant experience may be considered.
- Substantial hands-on experience with clinical trial and postmarketing ICSR intake, data entry, quality review, case assessment, narrative writing, follow-up, and regulatory submission, authoring Safety Management plan and SAE reconciliation is required.
- Demonstrated experience overseeing outsourced PV activities and managing vendor performance, quality issues, deviations, CAPAs, and escalations.
- Experience supporting a marketed product, product launch, REMS, patient support program, specialty pharmacy, call center, or other organized postmarketing data-collection program is strongly preferred.
- Demonstrated experience preparing for and supporting pharmacovigilance regulatory inspections and audits, including readiness activities, document requests, interviews, responses, commitments, CAPAs, and remediation, is required.
- Strong knowledge of global pharmacovigilance regulations and guidance, including applicable US postmarketing safety-reporting requirements, EU Good Pharmacovigilance Practices, ICH pharmacovigilance and clinical-safety principles, and relevant requirements in other major markets.
- Proficiency in ICSR concepts, MedDRA coding, seriousness, expectedness/listedness, causality documentation, reportability, special situations, Day 0, follow-up, duplicate management, and case narrative development.
- Experience with a validated global safety database; Oracle Argus Safety experience is preferred.
- Ability to interpret procedures, agreements, reporting matrices, data listings, compliance metrics, and quality trends and translate findings into practical corrective actions.
- Strong written communication, documentation, analytical, organizational, and problem-solving skills, with high attention to detail and sound judgment in escalating risk; ability to work independently in a fast-paced, global matrix environment and manage competing priorities without compromising quality or compliance.
- Proficiency with Microsoft 365 applications and collaboration tools; ability to work across global time zones and participate in time-sensitive safety or compliance escalations, with occasional travel as needed for vendor governance, audits, inspections, or team meetings.
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Pay Range:
The expected salary range for this position based on the primary location of South San Francisco, CA is $189,000-220,500. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.
