Signal Management Expert

Sanofi Group

Bridgewater, NJ 08807

Posted 1 month ago

Job Description

_Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail._


**JOB PURPOSE**


Within the Global Pharmacovigilance (GPV) organization, under the direction of the Signal Management Team Head, the Signal Management Expert (SME) will provide scientific leadership and/or people management leadership within the Signal Management Team. The SME is responsible for educating stakeholders on the use of state-of-the-art signal detection methodologies, signal management processes and tools.


The SME is responsible for providing strategic support, training, and expertise for the development and maintenance of excellence in the Signal Management component of activities and works in close collaboration with Global Safety Officers (GSO), Local Safety Officers (LSO), PV Scientists (PVS), Therapeutic Area Heads (TAH), and the GBU PV Heads in implementing a consistent signal management process across all GBU PV areas.


**PROFILE**


Knowledge and Skills


+ Expert in principles, theories, and practices of signaling research methods, techniques, data sources, surveillance methodologies and tools, applicable laws, rules, regulations, policies and procedures regulating the pharmaceutical industry, in addition to a general knowledge of the therapeutic areas and products


+ Prior experience of independently leading complex cross-functional projects


+ Sound understanding of GVP Module IX and other signal detection and management guidance


+ Ability to compose and produce technical or scientific reports, documents and related material


+ Make decisions or solve problems by using logic to identify key facts, explore alternatives, and propose quality solutions consistent with company policies and regulatory requirements; Monitor or track information and data


+ Experience working with vendors, especially for Pharmacovigilance services


+ Providing oversight to vendors performing PV activities, using knowledge of the relevant processes and medical judgment as needed


+ Strong oral and written communications skills, including presentations and publications. Ability to influence stakeholders across GPV and outside of GPV


+ Excellent meeting facilitation skills to achieve consensus among diverse stakeholder groups


+ Excellent teamwork and interpersonal skills


Basic Qualifications


+ A baccalaureate degree in a medical science is required. Additional advanced degree (MS, MSc, MSN, PharmD, etc.) or a degree with a concentration in public health is strongly preferred


+ At least 10 years of pharmaceutical/healthcare related industry experience


+ Global experience in signal detection science with at least 4 years of signaling work experience preferred


+ Project leadership experience, managing complex projects is preferred


+ Significant and demonstrable working knowledge of pharmacovigilance regulations and guidelines, including US, ICH and EU regulations


+ Experience working with vendors, particularly for pharmacovigilance activities, providing process-related and/or medical oversight is preferred


+ Knowledge of external sources of DM (e.g. FDA-FAERS, WHO-Vigibase, and EudraVigilance, etc.) is preferred


+ Knowledge of commonly used data mining methods and algorithms in pharmacovigilance for. both internal and external safety databases


+ Experience working with internal/company global safety databases


_At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society._


_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._


**_As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities._**


**_According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE._**


\#GD-SA


\#LI-SA


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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