Global Safety Officer

Role Summary

Global Safety Officer responsible for pharmacovigilance, risk management, and safety strategy across development programs. Leads cross-functional Safety Management Teams and internal Safety Analysis Teams, and represents PV positions with external partners and health authorities. Provides strategic safety input to development plans and due diligence activities. Location: Morristown, NJ; Cambridge, MA.

Responsibilities

• Provide PV and risk management expertise to internal and external customers
• Safety expert for product must have an attitude of continuous learning and understand the product attributes and science
• Maintain knowledge of product, product environment, and recent literature
• Maintain expertise in drug safety and PV, and understanding of international safety regulations and guidelines
• Lead cross functional Safety Management Teams (SMTs) and GPV 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
• 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 its internal and external stakeholders
• Continued visibility and Establishment of the credibility of GSO role/function and consequently GPV Signal Detection and Assessment
• Responsible for overseeing from multiple contributors signal detection and analysis
• Collaborate with Center of Excellence for Signal Detection and Data Mining and the Safety Epidemiology group
• Identify and implement proactive safety analysis strategies to further define the safety as well as Benefit Risk profile
• Lead the review of aggregate safety data and related activities as well as coordinate safety surveillance activities

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
• 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 and with a good sense of Prioritization of business critical deliverables
• Demonstrates leadership within cross-functional team environment
• Excellent teamwork and interpersonal skills are required
• Fluency in English (written and spoken)

Education

• M.D., D.O. or equivalent