{"id":1935085,"url":"https://alion.io/job/cytokinetics-senior-pharmacovigilance-operations-manager","title":"Senior Pharmacovigilance Operations Manager","company":{"id":1919595,"name":"Cytokinetics","domain":"cytokinetics.com","url":"https://alion.io/company/cytokinetics","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["South San Francisco, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":189000,"max":220500,"currency":"USD","period":"year","gross":null,"usd_annual":220500},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"GDPR","optional":false},{"name":"Oracle","optional":false}],"status":"live","first_seen_at":"2026-10-05T23:24:10Z","employer_posted_date":"2026-10-05","last_verified_at":"2026-11-06T05:43:38Z","board_verified":true,"closed_at":null,"days_open":31,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":31},"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.\nThe 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.\nThe 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.\nResponsibilities\nPerform 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.\nAssess case validity, Day 0, seriousness, expectedness, causality, reportability, MedDRA coding, follow-up needs, and overall case quality.\nDevelop/review clear case narratives and company comments, escalating cases requiring medical judgment or Safety Physician input.\nEnsure 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.\nReview and approve ICSRs before submission or partner exchange and manage complex case activities, including duplicates, linking, nullification, upgrades/downgrades, follow-ups, and transfers.\nAuthor and maintain Safety Management Plans, participate in study team meetings, and perform SAE reconciliation to ensure accurate and compliant safety data.\nMonitor 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.\nProvide risk-based oversight of global PV vendors and service providers across safety intake, processing, medical review, submission, literature, and reconciliation.\nMonitor vendor performance, compliance, quality, deviations, CAPAs, training, and trends; drive governance actions to closure.\nSupport vendor qualification, onboarding, training, change management, business continuity, audits, performance reviews, and PV/Safety Data Exchange Agreements.\nSupport oversight of the global safety database, including workflows, access, validated changes, data outputs, testing, migration, and system/process implementation.\nCoordinate safety-data reconciliation across internal and external sources and resolve missing cases, duplicates, mismatches, and transfer failures.\nSupport REMS and postmarketing PV activities, including AE collection, processing, reconciliation, vendor guidance, deviations/CAPAs, and regulatory safety reporting.\nDevelop and maintain scalable PV procedures, work instructions, tools, conventions, and training materials.\nInvestigate and trend deviations and quality issues; support CAPAs and effectiveness checks.\nLead PV inspection readiness and support audits and inspections, including preparation, evidence coordination, responses, and remediation.\nDrive process improvement, standardization, automation, workload planning, and implementation of regulatory or industry changes.\nServe as a senior PV operations SME across ICSR management, vendor oversight, reconciliation, and compliance; provide cross-functional leadership, risk communication, coaching, and work direction.\nSupport 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.\nQualifications\nBachelor's degree in life sciences, pharmacy, nursing, medicine, or a related healthcare or scientific discipline required; advanced degree or relevant professional certification preferred.\nMinimum 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.\nSubstantial 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.\nDemonstrated experience overseeing outsourced PV activities and managing vendor performance, quality issues, deviations, CAPAs, and escalations.\nExperience supporting a marketed product, product launch, REMS, patient support program, specialty pharmacy, call center, or other organized postmarketing data-collection program is strongly preferred.\nDemonstrated experience preparing for and supporting pharmacovigilance regulatory inspections and audits, including readiness activities, document requests, interviews, responses, commitments, CAPAs, and remediation, is required.\nStrong 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.\nProficiency in ICSR concepts, MedDRA coding, seriousness, expectedness/listedness, causality documentation, reportability, special situations, Day 0, follow-up, duplicate management, and case narrative development.\nExperience with a validated global safety database; Oracle Argus Safety experience is preferred.\nAbility to interpret procedures, agreements, reporting matrices, data listings, compliance metrics, and quality trends and translate findings into practical corrective actions.\nStrong 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.\nProficiency 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.\nPay Range:\nThe 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.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.\nPlease review our General Data Protection Regulation (GDPR) policy PRIOR to applying.\nOur passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.\nFraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers\nRecently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.\nHere are some ways to check for authenticity:\nWe do not conduct job interviews through non-standard text messaging applications\n\nWe will never request personal information such as banking details until after an official offer has been accepted and verified\n\nWe will never request that you purchase equipment or other items when interviewing or hiring\n\nIf you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at \n\nPlease visit our website at: www.cytokinetics.com\nCytokinetics is an Equal Opportunity 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