Senior PV Operations Manager — Equity & Impact in Cardio

Cytokinetics, Inc.; South San Francisco (CA); On-site; USD 189,000 - 221,000; Full time

Benefits offered by this job

Stock options

Health insurance

401k

Learning stipend

Paid time off

Job summary

Cytokinetics, Inc. is a specialty cardiovascular biopharmaceutical company focused on muscle biology and a pipeline for cardiac muscle dysfunction therapies.

The Senior Drug Safety Operations Manager provides senior-level leadership for postmarketing and clinical pharmacovigilance, overseeing ICSR handling, vendor oversight, REMS, and safety data reconciliation. The role partners with Drug Safety physicians, Regulatory Affairs, Quality, Clinical Development, Medical Affairs, and vendors to

Qualifications

• Minimum 8 years of pharmaceutical/biotech experience with at least 5 years in pharmacovigilance operations.
• Hands-on experience with ICSR intake, data entry, quality review, narrative writing, and regulatory submission.

Responsibilities

• Perform hands-on review and quality assessment of clinical-trial and postmarketing ICSR from diverse sources.
• Oversee safety data reconciliation, coding, and follow-up activities.
• Coordinate submission readiness and maintain inspection-ready safety documentation.
• Lead PV inspection readiness and vendor governance activities.
• Develop scalable PV procedures, work instructions, and training materials.

Skills

Strong written communication

PV operations

Vendor governance

Problem solving

Attention to detail

Education

Bachelor's degree in life sciences, pharmacy, nursing, medicine, or related field

Advanced degree or professional certification preferred

Tools

Oracle Argus Safety

Job description

Cytokinetics, Inc. is a specialty cardiovascular biopharmaceutical company focused on muscle biology and a pipeline for cardiac muscle dysfunction therapies.

The Senior Drug Safety Operations Manager provides senior-level leadership for postmarketing and clinical pharmacovigilance, overseeing ICSR handling, vendor oversight, REMS, and safety data reconciliation. The role partners with Drug Safety physicians, Regulatory Affairs, Quality, Clinical Development, Medical Affairs, and vendors to