Global Safety Officer

Role Summary

Global Safety Officer located in Morristown, NJ or Cambridge, MA. Lead pharmacovigilance and safety strategy across products, partnering with cross-functional teams and external partners to ensure proactive safety management and regulatory compliance.

Responsibilities

• Provide PV and risk management expertise to internal and external customers
• Serve as safety expert with continuous learning mindset, understanding product attributes and science
• Maintain knowledge of product, environment, and recent literature
• Maintain expertise in drug safety and PV, with understanding of international safety regulations and guidelines
• Lead cross-functional Safety Management Teams (SMTs) and GPV internal Safety Analysis Teams (SATs)
• Communicate 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
• Ongoing assessment of the safety status of the product
• Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling
• Review, preparation, and/or contribution to questions/requests from health authorities, ethics committees/IRBs, external partners
• Management of product safety alerts
• Ensuring the GPV’s position is well articulated to and understood by internal and external stakeholders
• Establish credibility of GSO role/function and GPV Signal Detection and Assessment
• Oversee signal detection and analysis from multiple contributors
• Collaborate with Center of Excellence for Signal Detection and Data Mining and the Safety Epidemiology group
• Identify and implement proactive safety analysis strategies to define safety and Benefit Risk profile
• Lead the review of aggregate safety data and coordinate safety surveillance activities

Qualifications

• M.D., D.O. or equivalent
• 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

Skills

• Excellent clinical judgment
• Articulate and clearly understood in telephone communications
• Capability to synthesize and critically analyze data from multiple sources supported by sound clinical reasoning
• 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 with prioritization of business-critical deliverables
• Demonstrates leadership within cross-functional team environment
• Excellent teamwork and interpersonal skills
• Fluency in English (written and spoken)

Education

• Medical Degree (M.D., D.O., or equivalent)