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Global Safety Officer

10+ years
Not Disclosed
10 Dec. 3, 2024
Job Description
Job Type: Full Time Education: MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Global Safety Officer
Location: Flexible (International collaboration required; English is the working language)


About the Job

At Sanofi, we are dedicated to chasing the miracles of science to improve lives globally. This role is a critical opportunity to shape the safety and benefit-risk profiles of our therapies, ensuring that patients, caregivers, healthcare professionals, and stakeholders receive the best possible outcomes.

The Global Safety Officer (GSO) will report directly to the Central Nervous System Therapeutic Area Head – General Medicine as part of the Global Patient Safety and Pharmacovigilance (PSPV) team within Global R&D. This position offers a chance to influence safety strategies across the entire lifecycle of our products in General Medicine.


Main Responsibilities

Expertise and Representation

  • Serve as the safety expert for products within your portfolio, providing pharmacovigilance expertise to internal and external stakeholders.
  • Represent safety positions in governance committees (e.g., Safety Management Committee, Benefit-Risk Assessment Committee) and during engagements with external partners, opinion leaders, and Health Authorities.

Safety Surveillance and Signal Detection

  • Conduct signal detection and lead safety surveillance activities.
  • Perform proactive risk assessments and develop risk management strategies and plans.
  • Monitor the effectiveness of risk management strategies.

Benefit-Risk Analysis

  • Collaborate cross-functionally to lead benefit-risk assessments, ensuring data-driven decision-making.

Documentation and Compliance

  • Ensure high-quality and consistent safety content in regulatory submission documents.
  • Draft safety responses to Health Authorities and lead the creation and validation of periodic safety reports (e.g., RMP updates, PSURs).

About You

Education & Work Experience

  • M.D. degree with 10+ years of relevant experience.
  • Board-certified/board-eligible (or equivalent) is preferred.
  • Strong pharmacovigilance experience is required.

Soft and Technical Skills

  • Exceptional clinical judgment and ability to critically analyze and synthesize data from multiple sources.
  • Strong written and verbal communication skills to explain complex clinical issues clearly.
  • Proven ability to develop sound risk assessments and document them effectively.
  • Demonstrates leadership and teamwork in cross-functional environments.
  • Capable of working under pressure and showing initiative.

Languages

  • Fluent in English (written and spoken).

Why Choose Us?

  • Be Part of Innovation: Collaborate with a global team at the forefront of medical advancements.
  • Career Growth: Explore endless opportunities to develop your talent, from promotions to international roles.
  • Supportive Environment: Enjoy a comprehensive rewards package, including healthcare benefits, wellness programs, and 14 weeks of gender-neutral parental leave.
  • Diversity & Inclusion: Work in an organization committed to fostering an inclusive, equitable workplace for everyone.

Our Commitment to Diversity and Inclusion

Sanofi is proud to provide equal opportunities to all, regardless of race, color, ancestry, religion, gender, nationality, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Join us to make extraordinary progress in healthcare.

Explore our Diversity Equity and Inclusion initiatives at sanofi.com.