# Director/Head, Pharmacovigilance at Orca Bio

- Company: Orca Bio
- What the company does: Orca Bio is helping to deliver the promise of cell therapy to patients without compromise. Backed by Lightspeed and Felicis.
- Company website: https://orcabio.com/
- Type: Startups
- Level: Principal and up
- Location: Remote
- Work setup: Remote
- Pay: $200K to $245K base salary per year (USD)
- Posted: 2026-09-04
- Apply by: 2026-10-19
- Apply: https://jobs.lever.co/orcabiosystems/329a7ea8-c1b4-4aa7-813a-6dbdc1a7dc6f
- Page: https://www.1752.vc/careers/jobs/orca-bio-director-head-pharmacovigilance/

## About the role

Position Summary: Reporting to our Chief Development Officer, the Director/Head of Pharmacovigilance will lead and develop the safety function, providing direct guidance to a small, dedicated team while driving end-to-end operational oversight.

## What they're looking for

- Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner, MD, or PhD
- 10+ years of experience in drug safety, safety science and risk management at a pharmaceutical, biotech, or CRO, including people leadership experience
- Knowledge of US and EU safety regulations pre and post marketing pharmacovigilance requirements
- Experience with pharmacovigilance risk management, preferably at a commercial-stage company
- Proficiency in preparing pre-marketing and post marketing safety regulatory documents, including PSURs, PBRERs, PADER, and Risk Management Plans
- Experience with clinical development, risk/benefit analysis, and safety assessment

Tags: Clinical Research & Development