Director, Drug Safety Physician

Medically qualified physician with post‑registration clinical experience.

Completed specialist training and/or clinical exposure in immunology and/or haemato‑oncology is strongly preferred.

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 regulatory requirements global pharmacovigilance regulatory requirements, including both pre-approval and post-marketing environments

Experience in the use and management of Drug Safety Databases and MedDRA coding.

Annual Bonus Program (Sales Bonus for Sales Jobs)

Ensure high quality, accurate, timely medical contributions to the safety evaluation of Kyowa Kirin products by leading Global Safety Team(s) to:

Ensure the safe development of new products and contributions of safety are delivered in a timely and effective manner to Development teams including the identification and implementation of safety strategies to deliver Company targets for products in both development and the market.

Determine the safety strategy for the preparation of global regulatory submissions for Marketing Authorization approvals (e.g.

Lead/ develop strategies for safety-related regulatory activities and support interpretation and authoring (in collaboration with the PV Scientist) of safety sections of documents including protocols, ICFs, IBs, clinical study reports (CSRs), Company Core Safety Information (CCSI), DSURs, PSUR, PBER, PADERRMP, REMS, Data Monitoring Committees reports, etc.

Lead the preparation of Benefit Risk Assessments for Kyowa Kirin products and provide appropriate support for implementation of the associated conclusions.

Develop proactive risk management strategies for marketed and / or investigational compounds ensuring that these are contained and implemented in appropriate strategies including Risk Management Plans.