Senior Pharmacovigilance Operations Manager Job at Cytokinetics, South San Francisco, CA

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  • Cytokinetics
  • South San Francisco, CA

Job Description

Cytokinetics seeks a Senior Pharmacovigilance Operations Manager to lead postmarketing and clinical drug-safety operations in South San Francisco. The role combines hands-on case review with strategic oversight of vendors, compliance, and regulatory readiness across marketed and investigational cardiovascular products.

Responsibilities

  • Review and assess clinical-trial and postmarketing individual case safety reports for validity, seriousness, causality, and regulatory reportability
  • Develop case narratives, company comments, and escalate complex cases requiring medical judgment to Safety physicians
  • Author and maintain Safety Management Plans; perform SAE reconciliation and monitor reporting timelines and compliance
  • Provide risk-based oversight of global pharmacovigilance vendors, monitoring performance, quality, deviations, and corrective actions
  • Lead pharmacovigilance inspection readiness activities, support regulatory audits, and drive process improvements and standardization

Requirements

  • Bachelor's degree in life sciences, pharmacy, nursing, medicine, or related healthcare field
  • Minimum 8 years pharmaceutical, biotechnology, or contract research experience
  • At least 5 years direct pharmacovigilance operations experience
  • Substantial hands-on ICSR intake, review, narrative writing, and regulatory submission experience
  • Demonstrated vendor oversight and performance management in pharmacovigilance settings
  • Experience supporting marketed products, product launches, REMS, or organized postmarketing programs
  • Experience preparing for and supporting pharmacovigilance regulatory inspections

Job Tags

Contract work

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