Director
Sanofi - Bridgewater, NJ

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Job Description: Job Summary:
The GSO is the safety expert and safety lead for Sanofi products

MAJOR DUTIES & RESPONSIBILITIES:
Internal & External Safety Expert:
  • Provide PV and risk management expertise to internal and external customers
  • 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) and GPE internal Safety Analysis
Teams (SATs)

  • Communicate with and represent PV position within project/product teams, 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 and Assessment:
  • 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 Safety Epidemiology
Submission Activities:
  • Represent safety position in cross functional submission teams
  • Ensure generation, consistency, and quality of safety sections in submisssion documents
  • Write responses or contributions to health authorities’ questions
  • Support preparation and conduct of Advisory Committee meetings
Report Writing:
  • Document, coordinate, review and 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 GPE Periodic Reports group for assigned projects
and products.

Major Challenges/Problems:
  • Providing product safety leadership within project teams having multiple and at times
competing priorities and timelines

  • Championing the GPE position within a large and complex organization
  • Determining the appropriate risk minimization and mitigation measures in light of B/R
assessment in coordination with different parties

  • Addressing internal and external customer queries, including those from Health Authorities, in
a rapid and effective manner and within appropriate timelines

The above challenges are effectively managed through strong leadership and communication skills paired with an assertive yet collaborative approach, a high level of medical and scientific expertise and integrity, effective time management skills, and dedication to patient safety.

Key Internal and External Relationships:
1. Internal: other GPE Units, R&D Units and Business Divisions, Scientific Core Platforms, Medical

and Regulatory Affairs, Franchise(s), Legal Department, Communication, Affiliates (APH)

2. External: Regulatory/Competent Authorities, Ethics Committee, Investigators, Data Monitoring

Committees, partners, CROs

Decision Making Authority:
  • Identify potential signals/issues of pharmacovigilance and evaluate product safety
  • Recommend/discuss and coordinate appropriate course of action
  • Ask project/product team for necessary amendments, labelling modifications/variations
  • Lead SMT and SAT
  • Approve safety regulatory and clinical documents including submission, transversal and
primary GPE documents as per SOP

Information/Decisions to be referred to hierarchy:
  • Transmission of any decision with impact on Study Conduct (e.g. Clinical Hold)
  • Transmission of any safety concerns for which GSO is informed (e.g. Health Authority
restriction/decision)

Requirements: Formal Education And Experience Required:
  • M.D. Degree
  • Board Certified/Board eligible, or equivalent, is preferred
  • Minimum 3 years total experience in international pharmacovigilance, or equivalent
relevant industry experience (e.g. clinical development) with relevant clinical experience

considered. Candidates may be considered if they have proven excellence in a similar

prior position, even if they have less than 3 years international PV experience.

Knowledge and Skills:
  • 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).
Knowledge And Skills Desirable But Not Essential:
Prior safety analysis documentation and experience responding to Health Authorities

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