Global Safety Officer, I&I

Role Summary

Global Safety Officer, I&I positioned in Cambridge, MA and Morristown, NJ. Leads pharmacovigilance, risk management, and safety governance activities across development plans; collaborates with cross-functional teams to provide proactive safety input and ensure high-quality safety documentation for submissions. Represents safety analyses within project teams, safety governance bodies, external partners, and authorities.

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

Qualifications

• MD 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
• Fluent in English (written and spoken)

Education

• MD Degree