Senior Drug Safety & PV Operations Leader (Hybrid)

Cytokinetics; South San Francisco (CA); Hybride; USD 189 000 - 221 000; Plein temps

Résumé du poste

Cytokinetics is seeking a Senior Drug Safety Operations Manager to provide senior-level operational leadership for postmarketing and clinical pharmacovigilance activities. The role oversees ICSRs, vendor governance, safety-data reconciliation, and regulatory submissions across marketed and investigational products.

The ideal candidate will have extensive PV experience, especially in inspection readiness, risk-based process improvement, and cross-functional collaboration with medical, regulatory,

Qualifications

• Minimum 8 years in pharma/biotech with PV ops.
• 5+ years direct pharmacovigilance experience; regulated submission.
• Experience overseeing outsourced PV activities and vendor governance.
• Strong knowledge of global PV regulations and ICH principles.

Responsabilités

• Perform hands-on review and quality assessment of clinical-trial and postmarketing ICSRs.
• Develop and review case narratives and company comments.
• Monitor vendor performance, quality, and regulatory timelines; escalate as needed.
• Lead PV inspection readiness activities and audits.

Connaissances

Regulatory oversight

Pharmacovigilance operations

Vendor governance

Attention to detail

Formation

Bachelor’s degree in life sciences or related field

Outils

Oracle Argus Safety

Microsoft 365

Description du poste

Cytokinetics is seeking a Senior Drug Safety Operations Manager to provide senior-level operational leadership for postmarketing and clinical pharmacovigilance activities. The role oversees ICSRs, vendor governance, safety-data reconciliation, and regulatory submissions across marketed and investigational products.

The ideal candidate will have extensive PV experience, especially in inspection readiness, risk-based process improvement, and cross-functional collaboration with medical, regulatory,