Location
Bridgewater, NJ | United States
Job description
Head of Pharmacoepidemiology Vaccines, Patient Safety Pharmacovigilance (PSPV), provides scientific and strategic leadership in epidemiology to demonstrate vaccines safety. The Head is accountable for defining the overall strategy, the design and method, and the execution/operation of post-approval safety studies (PASS) and the delivery of the results to characterize the risks of vaccines required by regulatory authorities, to inform Benefit – Risk evaluation, and to support internal decision making.
The Head is the leading expert in the best practices and innovations in epidemiology and real-world data (RWD). In this role, the Head actively contributes to PSPV, Regulatory & Labelling, and Medical strategies for characterizing and managing products risks and interacts directly with regulatory authorities. The Head is the primary Sanofi representative in public-private partnerships with industry, regulatory agencies, and academia to shape policies and innovations in the field of epidemiology and other related fields.
This is an opportunity to join a dynamic epidemiology group with a long history of innovations within a large biopharma company. As such, this is an excellent opportunity to expand the knowledge and experience through collaboration with highly innovative groups at Sanofi, and a great opportunity for growth.
Responsibilities
Lead a Pharmacoepidemiology Vaccines Team and mentor team personnel: professional and career development, state-of-the-art Pharmacoepidemiology methodologies and practices, epidemiology designs and methods for safety monitoring of post-marketing and investigational products.
Manage team resources to ensure timely and appropriate fulfillment of all activities.
Develop the overall strategy of the PASS, lead the design and the execution/operation of PASS.
Deliver PASS results to characterize the risks of vaccines required by regulatory authorities.
Lead the design and conduct of other epidemiologic studies (non-PASS) to inform benefit – risk evaluation and to support internal decision making.
Lead interactions with regulatory authorities about PASS and other epidemiology related areas.
Contribute to PSPV, Regulatory & Labelling, and Medical strategies for characterizing and managing vaccines’ risks.
Follow and apply regulatory guidelines and standards (such as ICH, CIOMS, FDA, EMA) on PASS, epidemiology, RWD, and other related fields.
Contribute to the development of the RWD strategy: identification and evaluation of RWD sources; acquisition, rapid access, and analysis of RWD sources for epidemiologic studies.
Contribute to the development of digital strategy for epidemiologic studies.
Serve as primary Sanofi representative in public-private partnership with industry, academia, and regulatory agencies to developed new, innovative methods and to shape policies and agendas of epidemiology and other related fields.
Basic Requirements
PhD degree in epidemiology or MD degree with an advanced degree (Master’s or doctorate level) in Epidemiology or other public health – related fields (or equivalent).
Minimum 15 years relevant experience in epidemiological research and at least 10 years of experience in pharmaceutical industry.
Demonstrated abilities to lead pharmacoepidemiology activities in pharmaceutical industry, including direct interaction with key regulatory and public health agencies and experience in both post-marketing and clinical development activities.
Excellent understanding of regulatory guidelines (such as ICH, CIOMS, FDA, EMA) on post-authorization safety studies.
Demonstrated leadership skills including team motivation, team management, ability to problem-solve and innovate, take initiative, and meet challenges.
Excellent organizational and planning capabilities.
Excellent critical analytics and clinical analysis skills.
Excellent teamwork and interpersonal skills.
Preferred Qualifications
Excellent understanding of statistics or biostatistics.
Excellent understanding of RWD sources, their strengths, and limitations.
Excellent track records of external partnerships and collaborations.
Demonstrated abilities to collaborate with industry or public-private working groups or projects.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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