Associate Director, Safety Epidemiology
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries – and growing – we look for talented people to grow our business, advance our science and contribute to our unique culture.
Purpose:
Contribute to the implementation of PE strategy and tactics through internal research activities and management of external vendors executing PE projects
Context and responsibilities:
The Safety Epidemiologist, Global Drug Safety is
•A global role based in Berkeley Heights, NJ
Reports (at a minimum) to:
•Lead Epidemiologist, Pharmacovigilance & Epidemiology
Responsible for:
• Executing epidemiologic research within specified therapeutic areas
• Participating in the activities of the Global Drug Safety & Risk management dept to support the Clinical Trials and Post-marketing Safety and Risk Management groups, and department physicians.
• Contributing epidemiologic knowledge and methods for regulatory documents.
Key Activities:
Trial Safety Support
• Participate in the creation of Development Risk Management Plans (DRMP)
• Provide and update epidemiologic information on the natural history of disease by relevant demographic and clinical parameters, including risk factors
• Provide and update background information on common comorbidities
• Provide and update background information on drug utilization and the safety profile associated with alternative therapies
Trial Safety regulatory documents
•Provide epidemiologic information for regulatory reports (e.g., EU Annual Safety Report and IND Annual Report, Investigator Brochure, IRB Updates/Responses, Clinical Study Reports, Integrated Summary of Safety, 120 Day updates)
Contribute to other regulatory requests (eg, orphan drug designations)
Analytic support for internal analysis of trial safety data
•On request, review trial safety data and provide analyses for safety questions
•Summarize key findings for incorporation into study reports and manuscripts
Safety Management Teams
•Attend Safety Management and Product Safety Review Meetings.
•Provide background epidemiologic information as requested
Risk Management
•Participate in the creation of Risk Management Plans (RMP)
•Update epidemiologic content of the dRMP as appropriate for regulatory submission (US, EU and ROW )
•Contribute epidemiologic perspectives and recommendations in the design of risk management initiatives
•Assist in designing studies that will track and measure the effectiveness of risk minimization activities
•Assist in the development of epidemiologic tactics (e.g., post-marketing studies, literature reviews, etc.) specified within the RMP to support the product’s safety profile in the commercial environment
Pharmacovigilance
•Contribute to ongoing safety PV processes
•Participate in the implementation and analysis of signal detection activities as requested
•Contribute to the development of Safety Topic Reviews
•Contribute to regulatory documents (eg, PSUR)
•Review relevant data required for response
•Provide findings from ongoing epidemiologic studies
•Contribute to the provision of exposure data for signal detection and regulatory documents…cont.
