Global Safety Officer, I&I

Role Summary

The Global Safety Officer, I&I leads pharmacovigilance and safety governance for assigned products, providing PV expertise to internal and external customers. Location: Cambridge, MA; Morristown, NJ. You will lead cross-functional safety activities, oversee signal detection, risk assessment, and regulatory submissions to support development and lifecycle management.

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
• Signal Detection & Assessment: Responsible for signal detection and analysis
• Signal Detection & Assessment: Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
• Signal Detection & Assessment: Identify and implement proactive safety analysis strategies to further define the safety profile
• Signal Detection & Assessment: Lead aggregate safety data review activities and coordinate safety surveillance activities
• Risk Assessment & Risk Management & Benefit-Risk Assessment: Provide proactive risk assessment
• Risk Assessment & Risk Management & Benefit-Risk Assessment: Co-lead benefit-risk assessment with other relevant functions
• Risk Assessment & Risk Management & Benefit-Risk Assessment: Develop risk management strategies and plans and monitor effectiveness
• Risk Assessment & Risk Management & Benefit-Risk Assessment: Collaborate with Center of Excellence for Risk Management and Epidemiology/Benefit-Risk groups
• Submission Activities: Represent safety position in cross functional submission teams
• Submission Activities: Ensure generation, consistency, and quality of safety sections in submission documents
• Submission Activities: Write responses or contributions to health authorities’ questions
• Submission Activities: Support preparation and conduct of Advisory Committee meetings
• Report Writing: Document, contribute to, coordinate, review and/or validate Periodic Reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report
• Report Writing: Serve as the medical safety expert to the GPV Periodic Reports group for assigned projects and products

Qualifications

• Required: 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
• Preferred: Board Certified/Board eligible, or equivalent

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)

Education

• MD Degree