Senior Director, Drug Safety & Pharmacovigilance
Remote (US)
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
Provide leadership in observational research and influence BeiGene’s global strategy to integrate epidemiology into the new drug development process and post marketing safety; Evaluate the overall R&D therapeutic area strategy globally to assist company in evaluation of the research portfolio; Improve design of clinical research programs, anticipate pre- and post-approval clinical safety issues, and contribute to their successful management; Serve as BeiGene’s epidemiological expert in meetings with Senior Management, Regulators, KOLs, etc.; Expand market awareness to improve the commercialization of BeiGene products
Essential Functions of the Job:
Responsible for:
Defining and advising on Global Epidemiology strategy and methodology across functions within BeiGene
Owning and executing pharmaco-epidemiological programs for BeiGene and competitor products
Leading or conducting all aspects of study analyses from secondary sources such as administrative claims or electronic health record data
Assisting Lead Product Safety Physicians and BeiGene staff in managing safety concerns
Managing supporting epidemiology staff
Safety Pharmacoepidemiology (PE) Elements of the Following Activities:
Global PE Strategy
Develop and implement a Global PE strategy
Develop and Implement PV-Epi Research Program for Safety Issues
Develop product specific safety elements into a single PV-Epi strategy
Contribute to the design of registries and other primary data collection studies
Create definition of publication needs; Identify vendors to support PV-Epi strategy; Execute Epi studies
Epidemiologic and Statistical Methods
Develop appropriate methods to support PV-Epi strategy
Background Rate of Safety Issues
Design and conduct studies, provide results to support PV activities and Safety Topic Review background
Epidemiologic Studies
Design protocols and conduct/contract study execution
Safety PV Processes
Create and manage safety PV processes for BeiGene and competitor products
Product Safety Surveillance Plan
Contribute to surveillance plan preparation for products in pre-market clinical trials for generation of hypotheses to investigate
Signal Detection and Analysis
Develop and maintain signal alert system and maintain signal detection methodology
Execute proactive, ongoing analysis of SAEs by system, compound, and TA to detect significant correlation/causation
Support trials safety analysis as required
Perform ongoing pharmacovigilance to determine and review for quality-related signals across SAEs
Maintain Product Safety Profile
Contribute to development and maintenance of product safety profile
Develop content for epidemiologic sections of risk management plans, benefit risk …