Collects, reviews, and analyzes adverse event reports from clinical trials to identify potential safety signals.
Supports the preparation and review of pharmacovigilance documents such as DSURs, dRMPs, and relevant clinical trial sections.
Collaborates with cross-functional teams including clinical operations, regulatory affairs, and medical affairs.
Oruka Therapeutics is developing novel biologics designed to set a new standard for treating chronic skin diseases like plaque psoriasis. They are an early-stage public company (Nasdaq: ORKA) building a core team, seeking top talent to contribute to an engaged, inclusive, and positive culture.
Advise product and engineering teams on end-to-end safety case workflows including intake, triage, validation, and data reconciliation.
Review and verify AI-driven platform outputs to ensure precision, accuracy, and safety compliance across case processing.
Translate macro industry trends and operational shifts in PV into actionable platform capabilities and long-term automation strategies.
Veeva Systems is a mission-driven pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue last fiscal year and are legally bound as a public benefit corporation to balance the interests of customers, employees, society, and investors.
Lead risk management and safety data review for assigned products, ensuring regulatory compliance.
Provide safety-related content for clinical and regulatory documents, and prepare for inspections.
Mentor a small pharmacovigilance team while driving end-to-end operational oversight.
Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies for blood cancer patients. We maintain a start-up culture of camaraderie and leadership by example, with a small dedicated team.