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).
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.
Formal Education & Experience
M.D. Degree
Board Certified/Board eligible, or equivalent, is preferred
Minimum 5 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 5 years international PV experience.
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