Director of Pharmacovigilance & Safety Strategy

Remote; San Francisco (CA); On-site; USD 250,000 - 360,000; Full time

Job summary

Orca Bio is seeking a Director/Head of Pharmacovigilance in San Francisco to lead the safety function across our cell-therapy programs. You will guide the pharmacovigilance team, review safety data, and interface with regulators to ensure compliant safety profiles for our products.

The role requires 10+ years in drug safety with leadership experience and a strong background in preparing PSURs, PBRERs, PADER, and safety risk management plans. An PhD/MD/PharmD is preferred.

Qualifications

• 10+ years in drug safety, risk management and safety science with leadership experience.
• Experience preparing regulatory safety documents (PSURs, PBRERs, PADER) and risk management plans.
• Knowledge of US/EU pharmacovigilance regulations pre/post marketing.

Responsibilities

• Lead safety function end-to-end for all Orca Bio products.
• Oversee safety data review, signal detection and risk assessment.
• Prepare safety content for regulatory filings and clinical documents.
• Ensure inspection readiness and interface with regulators during inspections.
• Mentor and manage pharmacovigilance staff and budget planning.

Skills

Pharmacovigilance leadership

Risk management

Regulatory writing

Data analysis

Cross-functional collaboration

Education

Pharmacist/PharmD/MD/PhD

Tools

MedDRA

Job description

Orca Bio is seeking a Director/Head of Pharmacovigilance in San Francisco to lead the safety function across our cell-therapy programs. You will guide the pharmacovigilance team, review safety data, and interface with regulators to ensure compliant safety profiles for our products.

The role requires 10+ years in drug safety with leadership experience and a strong background in preparing PSURs, PBRERs, PADER, and safety risk management plans. An PhD/MD/PharmD is preferred.