The Senior Medical Director is a senior drug safety expert for assigned products; maintains current knowledge of full product portfolio, monitors the safety profiles for assigned products and development compounds, and mentors junior physicians and scientists.
He/she is responsible for safety surveillance, risk management, and risk communication for assigned development and marketed products as well as medical assessment of individual adverse event reports, generation, and review of aggregate reports and safety documents, including labeling changes.
Works with the Therapeutic Area Head to develop the strategic roadmap for managing the safety of assigned products and development compounds. Participate in due diligence activities and special projects as might be needed
• Responsible for appropriate review of all safety data from all sources throughout the development process as well as marketed products Responsible for the conducting signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information
• Leadership of the Safety Review Teams for assigned products and development compounds, and responsible for the management of ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents for assigned products and development compounds
• Provides medical expert safety review input into all critical documents for clinical development of products (e.g., protocols, INDs, CCDS, IB, etc
• Works with the Therapeutic Area Head to develop the strategy and implementation of safety and benefit-risk management for assigned products.
• Provide input into and support the writing of periodic reports for assigned products; provide medical interpretation, review and approval for required reports
• Share Drug Safety and medical expertise and collaborate effectively with global counterparts in other functional areas Responsible for responses to inquiries from regulatory authorities on safety issues
• Perform thorough assessment of safety profiles for Due Diligence project
• Provide Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters
• Represent Global Drug Safety in leadership committees and activities both internally and externally when appropriate.
• Ensure communication of all safety issues that may impact the benefit-risk profile of assigned products/development compounds to Senior GDS, including the Internal Safety Review Committee (ISRC)
• Actively participating in Risk Management Committees and Safety Review Committees. Proactively mentor junior physicians and scientists.
• Participates in activities related to for inspection readiness as it pertains to assigned products and audit of clinical studies for assigned development compounds
• Maintaining therapeutic area knowledge and ongoing assessment of therapeutic area, competitive drugs and therapies. Minimum Qualifications:
Education & Experience Requirements:
At least 7 years of experience in pharmaceutical industry within Drug safety/Pharmacovigilance with both investigational and marketed products
• At least 5 years of experience with aggregate reporting, safety surveillance, signal management and/or Risk Management.
• At least 5 years of Clinical Patient Care experience preferred
• Previous experience in bioscience preferred
• Microsoft Word, Excel, Powerpoint, Outlook, and Adobe Acrobat
• Analytical and problem solving skills
• Oral and written communication and interpersonal skills
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.