Senior Pharmacovigilance Operations Manager

Cytokineticsis 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 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

• Bachelors 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 $00. The base pay offered will take into account internal equity and may vary depending on the candidates 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.

Our employees come from different backgrounds and we celebrate those differences. We are looking for the best candidates for our open roles but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team we would love to hear from you.

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Cytokinetics is an Equal Opportunity Employer