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Key Responsibilities:

  • Identify emerging safety signals and ensure appropriate escalation through internal safety governance pathways.
  • Contribute to the development and execution of pharmacovigilance strategies for clinical programs.
  • Maintain ongoing benefit-risk assessments incorporating disease severity and unmet medical need.

Ideal Candidate:

  • MD degree required with minimum 8 years of pharmacovigilance experience in the biopharmaceutical industry.
  • Strong expertise in global regulatory requirements including FDA, EMA, MHRA, PMDA, and ICH.
  • Experience with biologics, late-stage development, and regulatory submissions is a plus.

What We Offer:

  • Opportunity to work in a fast-paced, highly dynamic environment shaping the company culture.
  • Market competitive compensation and benefits including base salary, performance bonus, and equity.
  • Three weeks PTO, two one-week company-wide shutdowns annually, and dedicated paid sick leave.

Apogee Therapeutics

Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics for inflammatory and immune-mediated diseases. Founded in 2022 and publicly traded, the company operates with a fast-paced culture grounded in C.O.R.E. values: Caring, Original, Resilient, and Egoless.

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