Director, Drug Safety Physician

1w1 week ago

Kyowa Kirin

Princeton, US · Full-time · $250,000 – $275,000

About this role

Kyowa Kirin is a fast-growing global specialty pharmaceutical company applying biotechnologies to discover novel medicines in bone and mineral, intractable hematologic, hematology oncology, and rare disease areas. Headquartered in Princeton, NJ, it delivers therapies from drug discovery to commercialization. The Director, Drug Safety Physician leads Global Safety Team(s) for patient safety and regulatory compliance.

This role involves medical analysis of safety data, validation of safety signals, and implementation of processes for communicating emerging signals to stakeholders. The Director ensures high-quality safety contributions to product development and market strategies. Responsibilities include leading safety strategies for timely delivery to Development teams.

Work cross-functionally with Global Development, Franchise, and labeling Teams on risk management plans and regulatory submissions. Represent Pharmacovigilance in internal and external meetings discussing drug safety. Collaborate on authoring safety sections for protocols, ICFs, IBs, and aggregate reports like DSURs and PSURs.

Contribute to constant improvement of the Kyowa Kirin Pharmacovigilance System for global alignment with regulations and business needs. Lead preparation of Benefit Risk Assessments and signal detection activities. Provide updated safety profiles to senior management as required.

Requirements

Medical degree (MD or equivalent) with expertise in clinical pharmacology or related field
Deep knowledge of pharmacovigilance principles and drug safety practices
Experience leading global safety teams and cross-functional collaborations
Proficiency in global regulatory requirements including FDA, EMA, PMDA submissions
Skilled in safety signal detection, validation, and benefit-risk assessments
Familiarity with authoring safety documentation such as IBs, CSRs, RMPs, REMS
Ability to interpret complex safety data from clinical trials and post-marketing sources

Responsibilities

Lead Global Safety Team(s) to develop safety strategies ensuring patient safety and regulatory compliance for products in development and marketed
Perform medical analysis of safety data, validate and confirm safety signals
Implement processes for communication and management of emerging safety signals to internal and external stakeholders
Determine safety strategy for preparation of global regulatory submissions for Marketing Authorization approvals
Lead preparation of Benefit Risk Assessments and support implementation of associated conclusions
Develop proactive risk management strategies including Risk Management Plans for investigational and marketed compounds
Lead signal detection activities using data from all sources and drive Benefit Risk assessment reports
Provide medical review and interpretation of safety data for aggregate reports like DSURs, PSURs