Professional Experience & Educational Requirements • MD (physician) Minimum Years of Experience*: 2 years *Minimum Years of Experience to include medical (e.g. patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or and/or drug development Additional Qualifications • Disease area-specific knowledge preferred • Awareness of safety risk management internal and external environment, including applicable regulations and guidances • Knowledge of drug development process and post-marketing experience, including an understanding of safety context across the drug lifecycle • Ability to influence internal and external stakeholders • Ability to act independently, seeking guidance as appropriate; recognizes other colleagues’ areas of expertise and engages them effectively to achieve team objectives • Demonstrated leadership in day-to-day activities, including strong interpersonal and collaborative skills Technical Skills • Understanding of aggregate safety data and signal assessment methodology, and ability to perform benefit-risk assessments • Ability to perform safety data review, safety data assessment, Clinical safety signal identification, risk identification and risk management • Understanding of the scientific basis for therapies and drug-induced diseases • Ability to lead a cross functional team and lead through example, commitment and enthusiasm in a matrixed environment with minimal oversight • Strong scientific and medical knowledge, including fluency in the medical literature • Ability to integrate data to support benefit/risk decision-making • Understanding of statistics and analytical tools • Knowledge of global safety/regulatory issues and concerns as they relate to the business or clinical research-based compound development • Effective verbal and written communication skills in English.