Senior Pharmacovigilance Operations Manager at Cytokinetics in San Francisco, CA

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. 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 an