Global Safety Officer, I&I

Role Summary

Global Safety Officer, I&I — location Cambridge, MA or Morristown, NJ. Lead pharmacovigilance, safety strategy, and risk management for development-stage and marketed products, driving safety governance, cross-functional collaboration, and proactive safety input into development plans.

Responsibilities

• 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)
• Communicate with and represent PV analyses and PV position within project/product teams, in safety governance and benefit-risk governance activities and committees (e.g. Safety Management Committee, Benefit-Risk Assessment Committee), 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
• 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
• 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 Epidemiology/Benefit-Risk groups
• 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’ questions
• Support preparation and conduct of Advisory Committee meetings
• Document, contribute to, coordinate, review and/or validate Periodic Reports
• Serve as the medical safety expert to the GPV Periodic Reports group for assigned projects and products

Qualifications

• 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. Exceptionally, 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

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)