Director, Drug Safety Physician

Kyowa Kirin North America•Princeton, NJ

2d•$250,000 - $275,000

About The Position

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. Summary: 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 that are in development and / or marketed. The Director, Drug Safety Physician 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 Director, Drug Safety Physician, contributes to the constant improvement of the Kyowa Kirin Pharmacovigilance System to ensure the global PV strategy is in alignment with regulatory requirements and business needs.

Requirements

Medically qualified physician with post‑registration clinical 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 regulatory requirements global pharmacovigilance regulatory requirements, including both pre-approval and post-marketing environments
Proficient in MS Office Suite.
Experience in the use and management of Drug Safety Databases and MedDRA coding.
Requires up to 10% domestic and international travel

Nice To Haves

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

Responsibilities

Ensure high quality, accurate, timely medical contributions to the safety evaluation of Kyowa Kirin products by leading Global Safety Team(s)
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. North America, EMEA/ ROW, Japan and Asia Pacific) and ensure the delivery of high-quality safety documentation for those submissions.
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. Ensure success of such activities by close liaison with cross- functional Global Development, Franchise, and labeling Teams.
Lead signal detection activities using data from all sources and bring medical expertise to drive Benefit Risk assessment reports, support of Company Core Data Sheets and other similar reports and actions.
Provide medical review and interpretation of safety data for preparation of aggregate reports and ensure consistent messaging across all such reports and documents issued for both development and post-marketing purposes.
Contribute to the preparation and review of pharmacovigilance documentation for internal and external use by providing medical expertise to the preparation of responses to internal and external questions relating to the safe use of Kyowa Kirin products, safety issue work up etc.
Ensure that updated safety profiles of Kyowa Kirin products are provided to senior management as required.
Represent Pharmacovigilance at internal and external meetings where issues of drug safety are to be, or may be, discussed and lead presentation of the Global Safety Team’s recommendations on safety issues to cross- functional decision-making bodies and Teams (e.g. global PV Committee, R&D Committee, Evidence Generation Committee, Label Committee, Global Development Teams, Franchise Teams, etc).
Maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art pharmacovigilance processes and make recommendations leading to the improvement of the effectiveness and profile of the department.
Participate, when requested, in due diligence ensuring clear recommendations for progression to agreement.
Ensure that Ethics and Medical Compliance is applied within all pharmacovigilance activities.
To work cross functionally within project teams to meet Company objectives and to represent the Department of Pharmacovigilance in a team-oriented manner and delivering quality and timely input to meet the needs of the project team.
Any other activity that may reasonably be required.

Benefits

401K with company match
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
HSA & FSA Programs
Well-Being and Work/Life Programs
Life & Disability Insurance
Concierge Services
Long Term Incentive Program (subject to job level and performance)
Pet Insurance
Tuition Assistance
Employee Referral Awards