Senior Director, Drug Safety & Pharmacovigilance

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 assessments and regulatory deliverables
   

Aggregate Safety Reports

• Provide epidemiologic input to PSRs/PSURs/PBRERs as required

• Contribute to the development of the DSUR
   

Company Safety Committee (CSC)

• Contribute to the generation of materials for CSC review and support Safety Management Teams (SMTs)

• Contribute to package insert/ labeling update impact summaries for use by CSC

• Presentations and attendance as appropriate to the CSC
   

Product Labeling Core Data Sheet Creation

• Support safety input to core data sheet development
   

Issues management

• Contribute to crisis management through developing context, strategies, and generation of epidemiologic analyses for interpretation of context.
   

Regulatory and Safety Enquiries (Internal, External HCP and consumer)

• Review strategy and relevant data required for response

• Provide latest updates and findings from ongoing epidemiological analysis

• Response drafting (for relevant areas) and review data and draft response
   

Risk Management Plan development

• Contribute to RMP content determination and plan drafting

• Contribute to the review of emerging data again