Sanofi Hiring Global Safety Officer (Pharmacovigilance Role)

Sanofi Hiring Global Safety Officer (Pharmacovigilance Role)

18 May, 2022

About The Opportunity – Context

Join Sanofi as a Global Safety Officer (GSO). In this critical role, you will provide medical input on the safety evaluation of drugs under development and established drugs.

About Growing With Us – Key Accountabilities

In this role you will

Internal & External Safety Expert

  • Provide PV and risk management expertise to internal and external customers
  • Be the safety expert for product
  • Maintain knowledge of product, product environment, and recent literature
  • Maintain PV expertise, and understanding of international safety regulations and guidelines
  • Lead cross functional Safety Management Teams (SMTs)
  • Communicate with and represent PV analyses and PV position within project/product teams, in safety governance and benefit-risk governance activities and committees (e.g. Safety Management Committee, Benefit-Risk Assessment Committee), with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations
  • Provide strategic and proactive safety input into development plans
  • Support due diligence activities and pharmacovigilance agreements

Signal Detection & Assessment

  • Be responsible for signal detection and analysis
  • Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
  • Identify and implement proactive safety analysis strategies to further define the safety profile
  • Lead aggregate safety data review activities and coordinate safety surveillance activities

Risk Assessment & Risk Management & Benefit-Risk Assessment

  • Provide proactive risk assessment
  • Co-lead benefit-risk assessment with other relevant functions
  • Develop risk management strategies and plans and monitor effectiveness
  • Collaborate with Center of Excellence for Risk Management and Epidemiology/Benefit-Risk groups

Submission Activities

  • Represent safety position in cross functional submission teams
  • Ensure generation, consistency, and quality of safety sections in submission documents
  • Write responses or contributions to health authorities’ questions
  • Support preparation and conduct of Advisory Committee meetings

Report Writing

  • Document, contribute to, coordinate, review and/or validate Periodic Reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report
  • Serve as the medical safety expert to the GPV Periodic Reports group for assigned projects and products

About You – Profile

Qualifications/Education & Work Experience

  • M.D. Degree, Board Certified/Board eligible, or equivalent, is preferred
  • Minimum 3 years of total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered. Exceptionally, candidates may be considered if they have proven excellence in a similar prior position, even if they have less than 3 years of international PV experience
  • Experience in the immunology and inflammation therapeutic area strongly preferred

Competencies

  • Excellent clinical judgment
  • Capability to synthesize and critically analyze data from multiple sources
  • Ability to communicate complex clinical issues and analysis orally and in writing
  • Able to develop and document sound risk assessment
  • Demonstrates initiative and capacity to work under pressure
  • Demonstrates leadership within cross-functional team environment
  • Excellent teamwork and interpersonal skills are required
  • Fluent in English (written and spoken)

Apply through this Link

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