Lead the in-house pharmacovigilance function across clinical development and commercial products, owning the safety database, quality system, and compliance.
Serve as the senior safety physician, making benefit-risk determinations, adjudicating signals, and holding final safety decision authority.
Build and lead the PV team, set standards for AI-enabled safety processes, and ensure inspection readiness and health authority interactions.
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.
Lead product safety surveillance strategies and risk management for investigational products.
Oversee medical review of safety data and ensure compliance with global pharmacovigilance regulations.
Build pharmacovigilance infrastructure and manage vendor partnerships as the company grows.
Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. It is a growing biotechnology company with a startup culture focused on making a difference.
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.
Establish and maintain a system to collect all suspected adverse reaction reports for company products.
Ensure requests from competent authorities for benefit-risk information are answered fully and promptly.
Oversee safety profiles, emerging safety concerns, and post-authorisation safety study commitments.
PrimeVigilance is a mid-size pharmacovigilance service provider and part of Ergomed PLC, supporting pharma and biotech partners with drug safety, regulatory affairs, and quality assurance. With staff across Europe, North America and Asia, it values well-being.
Lead safety evaluations and benefit-risk assessments for assigned products.
Provide medical leadership for pharmacovigilance activities across development and marketed products.
Support regulatory submissions and health authority interactions, including preparing responses to RFIs.
Alphanumeric is a staffing and recruiting company that places professionals in contract roles with top organizations. This role is a 1-year contract with a major pharmaceutical company, supporting its global Safety Evaluation & Risk Management function.
Lead regulatory and PV deliverables for complex projects, ensuring compliance and timely execution.
Provide strategic regulatory guidance and support business development through proposals and budgets.
Mentor and train junior staff, prepare invoices, and ensure audit readiness.
PrimeVigilance is a global pharmacovigilance specialist helping clients navigate complex regulations while keeping patient safety at the center of every decision. With teams across Europe, North America, South America, Asia, and Australia, we foster a culture built on kindness, flexibility, growth, and belonging.