• location: Bridgewater, NJ
  • type: Contract
  • salary: $119.42 - $140.49 per hour

job description


Job Title: Director Global Patient Safety Immunology (MD)

Job 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 submission documents.
  • Write responses or contributions to health authorities.
  • 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.
Key Internal/External Relationships:

  • Internal: other GPE Units, R&D Units and Business Divisions, Scientific Core Platforms, Medical and Regulatory Affairs, Franchise(s), Legal Department, Communication, Affiliates (APH).
  • 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, labeling 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)
Education & Qualifications

  • M.D. Degree REQUIRED
  • Minimum 10 years total experience in international pharmacovigilance
  • Board Certified/Board eligible, or equivalent
  • 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 tea
  • Clinical development environment as a Clinical physician MUST
  • Strategically Motivated

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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