Sanofi Group Head Signal Management, Bridgewater, NewJersey in United States

JOB SUMMARY

The Signal Detection and Management (SDM) Lead is responsible for implementation and maintenance of the GPV SDM and data mining (DM) processes, guidelines and harmonization across product areas. S/he defines required standards and functions as the accountable senior management representative. The incumbent serves as a senior leader for all SDM processes and people, and works in close coordination with the Head of Global Safety Science (GSS) and the GSS Leadership Team as well as GPV Senior Leadership Team in setting the vision for the global department, translating that vision into operating priorities for the SDM function and guiding implementation of plans to achieve the vision. This position tracks progress and oversees the achievement of the overall strategic goals as cascaded to SDM activities.

KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTS

  • Expert understanding of international SDM processes, regulations, and timelines throughout product lifecycle.

  • Expert in DM of large external data sources.

  • Extensive understanding and application of scientific principles, theories, and concepts with the ability to apply to other disciplines and the ability to troubleshoot and develop solutions to a variety of complex problems.

  • Strong leadership & management capability within cross-functional team environment – track record in mobilizing teams of diverse skills and styles to meet agreed objectives & targets

  • Personnel management with ability to recruit, train, coach, motivate, provide performance improving feedback, and drive development and succession planning

  • Demonstrated capability to lead and manage global teams and multifunctional teams to the accomplishment of complex interdepartmental & international programs and projects

  • Excellent communication and influencing skills with strong capability to present strategies, policy & work processes to diverse audiences, geographies, departments, and organization levels

  • Advanced meeting facilitation skills to achieve consensus among diverse stakeholder groups

  • Strategic thinker, ability to identify root cause issues, demonstrated ability to apply subject matter knowledge, business, and process expertise to enable business improvement & minimize compliance risk

  • Ability to drive successful change; conveys strong business rationale and engages others to achieve shared ownership of solutions; able to develop and ensure implementation of improvement plans

  • Expert organization, prioritization, planning

  • Process orientation

  • Demonstrates leadership within cross-functional team environment

  • Excellent teamwork and interpersonal skills

  • Fluent in English (written and spoken)

EDUCATION

MD/PhD/PharmD with 8 - 10 years of PV experience, 4 years of clinical experience, and 4 years industry experience and required analytical skills;

OR

Masters level health care professional (Life Sciences degree, Nurse Practitioner, Dietitian or Physician Assistant) with 10 - 12 years industry experience and required analytical skills.

Required Analytical Skills:

  • Significant practical hands-on experience relevant to safety SDM and DM.

  • Working knowledge of external sources of DM (e.g. FDA-AERS, WHO-Vigibase, etc.)

  • Working knowledge of commonly used data mining methods and algorithms in pharmacovigilance

MAJOR DUTIES AND RESPONSIBILITIES

Management responsibilities:

  • Ensure functional management of SDM personnel

  • Provide managerial decision making and input to SDM personnel

  • Prioritization and resource allocation of SDM support

  • Ensure that the SDM objectives are achieved and compliance goals are met

  • Ensure alignment of SDM objectives, metrics and issue escalation with GBU Area Leaders and GPV head

  • Develop and progress processes to ensure state-of-the-art pharmacovigilance contributions.

Internal and external safety Expertise:

  • Set medical, scientific and SDM and DM standards for all GPV product areas

  • Provide SDM expertise within the Company as the senior GPV representative

  • Maintain expertise in SDM and DM and ensures implementation of state-of-the-art and innovative SDM techniques

Communication:

  • Interface with GBU areas, GSS functions, PV operations and PV Quality, Training and Compliance (QTC)

  • Senior contact for all SDM related matters to cross-functional groups, external companies and authorities

  • Member of the Global Safety Science Leadership team

Team development:

  • Supervise, mentor and develop SDM personnel (physicians, scientists)

  • Collaborate with GBU Leads and PV Scientist Lead to ensure that adequate training is provided to all GBU personnel.

  • Support GPV’s strategic direction and goals

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.

#LI-SA #GD-SA

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life