Associate, Pharmacovigilance Operations/Drug Safety

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.

Summary:

Responsible for reviewing adverse events and assisting in the determination of regulatory reporting for assigned investigational products

May serve as a liaison to internal and external stakeholders for AE reporting issues (i.e. site staff, CRAs, case processing vendor)

Works in collaboration with other functional groups such as data management, clinical operations, regulatory affairs, quality, and medical affairs

Summary:

Responsible for reviewing adverse events and assisting in the determination of regulatory reporting for assigned investigational products

May serve as a liaison to internal and external stakeholders for AE reporting issues (i.e. site staff, CRAs, case processing vendor)

Works in collaboration with other functional groups such as data management, clinical operations, regulatory affairs, quality, and medical affairs