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Job Title: Director Global Patient Safety Immunology (MD)
Job Location: Bridgewater, NJ
Job Duration: 6 Months
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.
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.
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, 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)
Qualifications - External
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
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