Global Safety Officer, Immunology & Inflammation

Role Summary

Global Safety Officer, Immunology & Inflammation. Location: Cambridge, MA; Morristown, NJ.

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

Impact

• 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

Knowledge And 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. Degree
• At least 2 years of clinical experience within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization
• Previous experience in pharmacovigilance and/or clinical experience in the therapeutic area preferred (not required)