Orca Bio is helping to deliver the promise of cell therapy to patients without compromise. Backed by Lightspeed and Felicis.
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
More about this role
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
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.
- Lead risk management and mitigation activities for assigned products, leading safety data review and analysis for all products.
- Responsible for providing safety-related content for all clinical and regulatory documents.
- Lead inspection preparedness efforts for pharmacovigilance and represent...
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