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Global Safety Officer - Immunology Global Safety Officer - Immunology
Ref No.: 18-11628
Location: Bridgewater, New Jersey

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.

International Pharmacovigilance experinece is required
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).