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Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to treat blood cancer. The company is redefining the transplant process with purified, high-precision cell therapies designed to improve survival rates and reduce risks such as graft-versus-host disease.
Reporting to the Chief Development Officer, the Director/Head of Pharmacovigilance will lead and develop the safety function for the organization. This role involves providing direct guidance to a small, dedicated team while driving end-to-end operational oversight of pharmacovigilance activities. The Director will be responsible for establishing and maintaining robust safety monitoring systems, ensuring compliance with regulatory requirements, and managing adverse event reporting and analysis. Key responsibilities include developing pharmacovigilance strategies, overseeing safety data collection and evaluation, coordinating with clinical and regulatory teams, and ensuring timely communication of safety findings to internal stakeholders and regulatory authorities.
The ideal candidate will have extensive experience in pharmacovigilance, drug safety, or related regulatory affairs within the pharmaceutical or biotechnology industry. Strong leadership capabilities are essential, as the role requires building and mentoring a team while managing complex safety operations. The Director should be comfortable working in a fast-paced, commercial-stage biotech environment and have a track record of implementing effective safety systems and processes. Excellent communication skills, attention to detail, and a deep understanding of regulatory frameworks (FDA, ICH guidelines) are critical for success.
