Senior Pharmacovigilance Operations Leader (Hybrid)

Cytokinetics; San Francisco (CA); Hybrid; USD 189,000 - 221,000; Full time

Benefits offered by this job

Stock options

RSUs

Health, dental, vision insurance

401(k) with employer match

Wellness stipend

Job summary

Cytokinetics, a specialty cardiovascular biopharmaceutical company with 25+ years of scientific innovations, seeks a Senior Drug Safety Operations Manager in San Francisco. You will provide senior-level operational leadership for postmarketing and clinical pharmacovigilance, oversee IC SR processes, and drive risk-based PV governance across vendors and regulatory activities.

Responsibilities include hands-on ICSR review, case narratives, regulatory submissions, REMS support, and inspection

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 Plans 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, REMS, or patient support programs is strongly preferred.

Responsibilities

• Perform hands-on review and quality assessment of ICSRs from diverse sources and ensure case quality.
• Provide risk-based oversight of global PV vendors and service providers; monitor performance, deviations, CAPAs, and training.
• Develop and maintain scalable PV procedures, work instructions, tools, and training materials.
• Coordinate safety-data reconciliation across internal and external sources and resolve missing cases or transfer failures.
• Lead PV inspection readiness activities and support audits and regulatory responses.

Skills

Pharmacovigilance operations

ICSR management

Vendor oversight

Regulatory reporting

Safety data reconciliation

Education

Bachelor's degree in life sciences or related

Tools

Oracle Argus Safety

MS 365

Job description

Cytokinetics, a specialty cardiovascular biopharmaceutical company with 25+ years of scientific innovations, seeks a Senior Drug Safety Operations Manager in San Francisco. You will provide senior-level operational leadership for postmarketing and clinical pharmacovigilance, oversee IC SR processes, and drive risk-based PV governance across vendors and regulatory activities.

Responsibilities include hands-on ICSR review, case narratives, regulatory submissions, REMS support, and inspection