Director, Lead Global Product Saftey Physician (Approved Products)
Posted July 11, 2006
Ten years relevant clinical experience
Location - Summitt, NJ
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JOB DESCRIPTION:
Purpose •To create and maintain a single interpretation of global safety data for defined products •To identify and manage safety concerns with approved products •To assist the Clinical Development function in identifying and managing safety concerns for defined approved products •To manage pharmacovigilance physicians •To liaise with trials safety scientists and teams engaged in trials of approved products. Context and Responsibilities The Director, lead Global Product Safety Physician (Approved Products) is: •A global role, based in Summit, NJ Reports (at a minimum) to: •Senior Director, Head of Global Pharmacovigilance & Epidemiology • Responsible for: •Identifying and managing safety concerns for approved products •Assisting Medical Affairs & product teams in the identification and handling of product safety concerns •Maintaining knowledge of safety profiles for defined products, including both company and competitor products
JOB REQUIREMENTS:
Preferred Role Qualifications, Experience, Knowledge & Competencies
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education and experience or the equivalent. Qualifications •Minimum of MD (or international equivalent) plus accredited residency •Accredited fellowship or clinical experience in relevant therapeutic area specialty is preferred • Experience •Ten (10) years relevant clinical experience, including training •Five (5) years pharmaceutical/biotechnology industry experience •Previous management experience preferred Knowledge •Mastery of global regulatory requirements for pharmacovigilance •Clinical knowledge of therapeutic area patient populations and drug class •Proficiency in signal recognition and statistical techniques •Issue and crisis management
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