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Global Safety Officer

10+ years
Not Disclosed
10 Dec. 4, 2024
Job Description
Job Type: Full Time Education: M.D 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: Global (Sanofi)
Department: Global Patient Safety & Pharmacovigilance (PSPV) – Global R&D


About the Job

Sanofi is a global healthcare company committed to improving lives through scientific innovation. As a Global Safety Officer within the General Medicine Therapeutic Area, you will play a critical role in providing medical input for drug safety evaluations throughout their life cycle. You will join the Global Patient Safety & Pharmacovigilance (PSPV) team, contributing to the benefit-risk assessment of our therapies and ensuring their safety across diverse global markets.

As part of Sanofi’s PSPV aspiration, you will be working in an organization dedicated to optimizing the safety profiles of our treatments, striving to best serve patients, caregivers, healthcare professionals, and stakeholders.


Main Responsibilities

Safety Expertise & PV Analysis

  • Act as the safety expert for assigned products, providing pharmacovigilance expertise to internal and external customers.

  • Lead signal detection and safety surveillance activities for products within your portfolio.

  • Provide proactive risk assessments and develop risk management strategies and plans.

Benefit-Risk Assessment & Governance

  • Co-lead benefit-risk assessments in collaboration with cross-functional teams.

  • Represent pharmacovigilance analyses and positions during safety governance, including the Safety Management Committee and Benefit-Risk Assessment Committee.

  • Communicate with Health Authorities, external partners, and key opinion leaders regarding safety matters.

Regulatory Submissions & Responses

  • Ensure the generation and quality of safety sections in submission documents and provide timely responses to health authorities' safety inquiries.

  • Coordinate and review periodic reports such as Risk Management Plans (RMP) and Periodic Safety Update Reports (PSUR).

Leadership & Cross-functional Collaboration

  • Lead or participate in cross-functional teams, demonstrating leadership in guiding safety assessments.

  • Engage in internal and external negotiations, ensuring alignment and regulatory compliance on safety issues.


About You

Education & Work Experience

  • M.D. degree with 10+ years of relevant experience. Board certification (or equivalent) preferred.

  • Proven experience in pharmacovigilance is essential.

Soft Skills & Competencies

  • Excellent clinical judgment and the ability to synthesize complex data from multiple sources.

  • Ability to effectively communicate complex clinical issues and analyses both orally and in writing.

  • Strong risk assessment and management skills.

  • Demonstrates initiative, resilience, and the ability to work effectively under pressure.

  • Proven leadership in cross-functional teams, with excellent teamwork and interpersonal skills.

Languages

  • Fluent in English (both written and spoken).


Why Choose Us?

  • Endless Opportunities: Explore diverse career growth opportunities within Sanofi, both locally and internationally.

  • Rewarding Experience: Competitive rewards package and benefits, including high-quality healthcare and at least 14 weeks’ gender-neutral parental leave.

  • Inclusive Culture: Sanofi embraces diversity and equality in the workplace, offering a welcoming environment for all.


Sanofi’s Commitment to Diversity

At Sanofi, we believe progress comes from people of all backgrounds working together. We are committed to equal opportunity for all individuals, regardless of gender, race, nationality, sexual orientation, age, disability, or other personal characteristics.


Join us and make a meaningful impact on global healthcare. Let’s pursue progress and discover extraordinary together!