Global Literature Surveillance Strategy and innovation Lead

Global Literature Surveillance Strategy And Innovation Lead

The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-edge safety group, to enable us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers. Global Health Authorities (HAs) have an expectation that medical literature is routinely surveilled for safety information relevant to the Marketing Authorization Holder's (MAH's) products. The Global Literature Surveillance Team within PSPV ensures that the Global Medical Literature Surveillance is conducted in accordance with regulatory expectations and PSPV's commitment to patient safety. Information derived from the global literature supports Individual Case Safety Report (ICSR) identification, signal and risk management activities, and periodic reporting including the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR) submissions. This work requires interactions across multiple teams and functions within PSPV and the larger R&D organization and involves coordination across multiple service vendors. As the quality and accuracy of literature surveillance reflects directly on PSPV, R&D, and Sanofi, the mission of the Global Literature Surveillance Team is to help ensure all relevant safety data are properly identified and assessed to support Sanofi and our commitment to quality and patients.

Main Responsibilities

The Global Literature Surveillance And Innovation Lead will :

• Oversee the global literature surveillance processes for both routine and ad-hoc surveillance.
• Manage the global literature team including internal and external literature experts.
• Oversee vendors supporting literature processes including screening, translations, article ordering (copyright), and quality assurance.
• Business owner for the Pharmacovigilance Literature Database.
• Remain current with the evolving landscape of AI / machine learning as well as the regulatory environment related to these technologies as relates to literature surveillance.
• Partner with PSPV digital team to continuously assess new AI powered tools and processes that will maximize literature screening efficiencies.
• Actively contribute to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality / accuracy screening.
• Create, implement, and finalize internal process and standards documents relating to literature surveillance processes and deliverables.
• Manage all stakeholder needs including ICSR, Signal and Risk management, Periodic Reporting.
• Support affiliate and partner literature needs.
• Help define and guide PSPV's literature vision and ensure alignment with an evolving product portfolio.
• Support audits and inspections as required.
• Understand AI and machine learning as applicable to literature screening and translation.
• Strong knowledge of literature search alert creation and application to global literature repositories such as Embase and Medline.

Required Experience and Education

Minimum 10 years total experience in pharmacovigilance with both marketed and development products. Pharm.D. or BS in health science or related field (pharmacy, nursing preferred) Proficiency with working in a strongly regulated environment such as those defined in the Good Pharmacovigilance Practices. Experience in the Pharmaceutical or Biotechnology industry. Prior experience leading teams and projects. Experience with ICSRs, periodic safety reports and clinical overviews (Type II variations). Strong leadership and communication skills. Computer literacy especially in Windows based programs.

Soft Skills

Ability to manage team priorities across multiple resource types. Flexibility to adapt to changing priorities and delays. Ability to deal with multiple stakeholders across R&D. Ability to work in a global, multi-entity, multi-cultural environment across time zones. Excellent teamwork and collaboration skills. Experience with literature surveillance and assessment for PV and medical purposes.

Languages

English

Why Choose Us?

Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. 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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