Orca Bio is helping to deliver the promise of cell therapy to patients without compromise. Backed by Lightspeed and Felicis.
About the role
The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market.
What they're looking for
- A minimum degree of bachelor's or higher degree in a clinical or closely related field
- 2-3 years of related experience gained in a biotech or pharmaceutical company
- 1-2 years of experience in cellular therapy, stem cell transplant, and/or oncology strongly strongly preferred
- Post-marketing experience desirable
- Proficiency in the Argus safety database system
- Working knowledge of MedDRA and WHODrug coding preferred
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.
- 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
- Serves as the main point of contact for any adverse event questions, requests, and/or reviews within the safety and...
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