Global Safety Officer

Responsibilities

• Provide PV and risk management expertise to internal and external customers
• Maintain knowledge of product, product environment, and recent literature
• Lead cross functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs)
• Communicate with and represent PV position within project/product teams
• Responsible for signal detection and analysis
• Collaborate with Center of Excellence for Signal Detection and Safety Epidemiology group
• Identify and implement proactive safety analysis strategies
• Provide proactive risk assessment
• Represent safety position in cross functional submission teams
• Document, coordinate, review and validate Periodic reports

• M.D. Degree or equivalent
• Board Certified/Board eligible, or equivalent, is preferred
• Minimum 3 years' total experience in international pharmacovigilance, or equivalent relevant industry experience
• Candidates may be considered with proven excellence in a similar prior position even with less experience
• Excellent clinical judgment
• Capability to synthesize and critically analyse 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)

Expertise in pharmacovigilance and risk management, with a strong ability to synthesize and analyze clinical data. Proven leadership in cross-functional teams and effective communication of complex clinical issues.