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Drug Safety Associate I Drug Safety Associate I
Ref No.: 17-15689
Location: Bridgewater, New Jersey
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).

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.
Duties
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.