Director, Drug Safety Physician

Overview

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization.

In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

The Director, Drug Safety Physician is the Lead of the Global Safety Team(s) to develop safety strategies to ensure patient safety and regulatory compliance for products in development and/or marketed. The Director is responsible for medical analysis of safety data, validation and confirmation of safety signals, and implementation of processes for communication and management of emerging signals and safety data to internal and external stakeholders.

The role contributes to the continuous improvement of the Kyowa Kirin Pharmacovigilance System to align the global PV strategy with regulatory requirements and business needs.

• Lead Global Safety Team(s) to ensure high-quality, accurate, and timely medical contributions to the safety evaluation of Kyowa Kirin products, including identifying and implementing safety strategies to deliver company targets for products in development and the market.
• Determine safety strategy for global regulatory submissions (e.g., North America, EMEA/ROW, Japan, Asia Pacific) and ensure delivery of high-quality safety documentation for those submissions.
• Lead/develop strategies for safety-related regulatory activities and support interpretation and authoring of safety sections of documents (protocols, ICFs, IBs, CSRs, CCSI, DSURs, PSUR, PADER, REMS, DMC reports, etc.) in collaboration with the PV Scientist.
• Lead the preparation of Benefit Risk Assessments for Kyowa Kirin products and support implementation of conclusions.
• Develop proactive risk management strategies for marketed or investigational compounds and ensure these are contained and implemented in appropriate strategies (e.g., Risk Management Plans) with cross-functional liaison to Global Development, Franchise, and labeling teams.
• Lead signal detection activities using data from all sources and drive Benefit Risk assessment reports, support of Company Core Data Sheets, and related actions.
• Provide medical review and interpretation of safety data for aggregate reports and ensure consistent messaging across development and post-marketing communications.
• Contribute to the preparation and review of pharmacovigilance documentation by providing medical expertise for responses to internal and external questions regarding safe use of Kyowa Kirin products and safety issue workups.
• Ensure updated safety profiles are provided to senior management as required.
• Represent Pharmacovigilance at internal and external meetings and present the Global Safety Team’s safety recommendations to cross-functional decision-making bodies and teams (e.g., PV, R&D, Evidence Generation, Label, Global Development, Franchise).
• Maintain awareness of regulatory guidance updates and pharmacovigilance processes; recommend improvements to the department’s effectiveness.
• Participate in due diligence as requested, with clear recommendations for progression to agreement.
• Ensure Ethics and Medical Compliance in all pharmacovigilance activities and work cross-functionally within project teams to meet company objectives.
• Any other activity reasonably required.

Education
Medically qualified physician with post‑registration clinical experience. Completed specialist training and/or clinical exposure in immunology and/or haemato‑oncology is strongly preferred.

Experience
Minimum of eight (8) years’ experience in pharmacovigilance or a related area of clinical development in biotechnology or pharmaceutical industry. Demonstrated in-depth knowledge of global pharmacovigilance regulatory requirements, including pre-approval and post-marketing…