What seniority level is this role?

Orca Bio targets mid-level candidates for this position.

Associate, Pharmacovigilance Operations/Drug Safety at Orca Bio

Joblaze summary

In this role, the associate focuses on reviewing adverse events and supporting regulatory reporting for investigational products, ensuring compliance and safety in the drug development process. Key skills include a solid understanding of pharmacovigilance practices and the ability to collaborate effectively with various teams, such as clinical operations and regulatory affairs. This position is well-suited for individuals with a background in life sciences or a related field, ideally at an early-career level. Orca Bio, a commercial-stage biotechnology company, emphasizes innovation in cell therapies, making this an exciting opportunity for those passionate about improving patient outcomes.

Joblaze insights

Listed 10 days ago on Joblaze — tracked directly from Orca Bio's career page.
Orca Bio has 53 other open roles including Clinical Research Associate, General Manager, Commercial Manufacturing Facility, Director/Head, Pharmacovigilance.

Quick facts

What seniority level is this role?: Orca Bio targets mid-level candidates for this position.
Is this full-time or contract?: Full-time for this Associate, Pharmacovigilance Operations/Drug Safety role at Orca Bio.

From the original posting

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

Associate, Pharmacovigilance Operations/Drug Safety

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