Senior Pharmacovigilance Operations Lead — Hybrid

Regulatory Toolkit; South San Francisco (CA); Hybrid; USD 189,000 - 221,000; Full time

Job summary

Cytokinetics, a specialist cardiovascular biopharmaceutical company, is seeking a Senior Drug Safety Operations Manager to lead postmarketing and clinical pharmacovigilance activities. You will oversee ICSR intake, data quality, safety narratives, and regulatory submissions while guiding outsourced PV vendors and ensuring inspection readiness.

The role partners with Drug Safety physicians, Regulatory Affairs, Quality, and Commercial teams to implement scalable PV processes, manage REMS, and

Qualifications

• Bachelor's degree in life sciences, pharmacy, nursing, medicine, or a related discipline is required.
• Minimum 8 years in pharma/biotech with 5+ years in pharmacovigilance operations.
• Experience overseeing outsourced PV activities and vendor performance.

Responsibilities

• Provide senior-level leadership and oversight for postmarketing and clinical PV activities.
• Review IC(S)R intake, data quality, case narratives, and regulatory submissions.
• Oversee outsourced PV vendors, ensure inspection readiness, and manage safety data reconciliation.

Skills

Pharmacovigilance operations

ICSR management

Vendor governance

Regulatory submissions

Education

Bachelor's degree in life sciences or related field

Tools

Oracle Argus Safety

Job description

Cytokinetics, a specialist cardiovascular biopharmaceutical company, is seeking a Senior Drug Safety Operations Manager to lead postmarketing and clinical pharmacovigilance activities. You will oversee ICSR intake, data quality, safety narratives, and regulatory submissions while guiding outsourced PV vendors and ensuring inspection readiness.

The role partners with Drug Safety physicians, Regulatory Affairs, Quality, and Commercial teams to implement scalable PV processes, manage REMS, and