• Full Time
  • Florida
Director PV Epidemiology
Full description
The Director, Pharmacovigilance (PV) Epidemiology, contributes to the leadership of the PV Epidemiology function within the PV Division at Astellas. The Director makes important contributions in the following areas: development and execution of PV Epidemiology functional strategy, leadership and implementation of non-interventional post-authorization safety study (NI-PASS), process excellence, and driving innovation in the application of Epidemiology in PV and M&D. Essential Job Responsibilities: The PV Epidemiology Team Mission is to use epidemiological expertise in PV to (1) Lead development and execution of NI-PASS for regulators, (2) Identify/generate/summarize scientifically sound epidemiological evidence for PV deliverables and Regulatory submissions (eg RMPs, SERs, ODAs, PIPs), and (3) Collaborate, Consult and Innovate.
The PV Epidemiology Vision is to bring our unique epidemiologic skills to gain rapid and credible insights from real-world data to improve understanding of the benefit-risk profile of our drugs, increase efficiencies and drive innovation in pharmacovigilance and drug development for the betterment of patients. The Director in PV Epi plays an important role in aiding PV Epidemiology to deliver on its Mission and realize its Vision. The individual has a responsibility for:
• Contributing to a focus on pharmacoepidemiology and healthcare database insights & studies to address portfolio- and product-related regulatory-associated questions in both the pre- and post-marketing setting
• Taking a lead on regulatory-orientated (and voluntary) NI-PASS
• Providing methodological insights in observational research to PV and partners across M&D
• Supporting delivery of high scientific quality, cross-portfolio Epidemiology deliverables
• Developing & implementing strategies to address evidence gaps in product safety using Real World Evidence
• Utilizing advanced pharmacoepidemiology tools and methods for safety signal investigations
• Driving PV
Epidemiology innovations in partnerships, deliverables and methodological approaches
• Ensuring that Epidemiology activities comply with regulatory obligations worldwide
• Playing a role in PV and M&D, including contributing to change initiatives
• Identifying opportunities to bring epidemiology developments to our company work in developing new products and in ensuring appropriate use of our products for value to patients
• Working closely with partners at all levels to lead and deliver on the above activities, including the Executive Director, Head, PV Epidemiology, other PV Epidemiology and RM staff, management in PV, TA and Product PV Medical Safety Leads, the Office of the EU-QPPV and Japan Safety Control Officer, and Others.
Quantitative Dimensions: This position’s impact can be measured across the following dimensions, by ensuring:
• PV Epidemiology activities comply with regulatory obligations worldwide, working closely with the Executive Director, and the Offices of the QPPVs (EU, Japan)
• High scientific quality and consistency of epidemiologic input into pre- and post-approval activities, including NI-PASS
• Efficient and effective logistics and operations, and smooth and timely epidemiology-focused input and deliverables
• This position adds value to the success of drug development programs and to life-cycle management, through delivery of high-quality evidence generation activities
• This position provides added value as a key partner for the Medical Safety Science function, which is responsible for safety signal evaluation at a product level across the portfolio Organizational Context:
• Reports directly to the Executive Director, Head, PV Epidemiology, together with other Epidemiologists (at Associate Director and Director levels)
• May mentor other scientific staff and contractors; no direct reports
• Interacts and collaborates with peers in PV, including in Risk Management, Signals, Aggregate Safety Assessment, Medical Safety, Offices of the QPPV
• Interacts and collaborates with staff across M&D (including staff in Medical Affairs, Development, and Regulatory Affairs) and Astellas (including RWE in Advanced Informatics & Analytics)
• May lead PV Epi-related (study) activities in matrix teams, notably Core Teams, Safety Management Teams, Core Medical Teams, and Benefit-Risk Teams, and at governance committees, eg MAC and MA-PAC
Qualifications: Required
• PhD in Epidemiology or (or equivalent, eg 1st author scientific publications)
• At least 5-10 years pharmaceutical/health related industry experience and 5 years of Epidemiology research experience.
• Leadership responsibilities in previous roles, with evidence of success
• Proven impacts in epidemiology and from NI-PASS
• Good understanding of quantitative methods and strong ability to interpret and communicate quantitative evidence
• Considerable knowledge of PV regulations and guidelines, including US, ICH and EU regulations
• Quality input to proposals, scientific protocols, and reports
• Thoughtful problem-solver, explores alternatives, and proposes quality solutions
• Excellent English-language skills, spoken and written
• Ability to work and influence effectively in teams, across cultures and functions, and at all levels
• Global experience in Epidemiology preferred.

To apply for this job please visit orbiterrecruiting.com.