The Medical Director is the drug safety expert for assigned products; maintains current knowledge of full product portfolio and safety profiles for products.
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.
This role provides drug safety support for internal and external customer.
• Responsible for appropriate review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products and development compounds
• 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 and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
• Works with the Therapeutic Area Head to develop the strategy and implementation of safety and benefit-risk management for assigned products.
• Responsible for key content of Risk Management documents (RMPs, REMS).
• 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 with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
• Provide expert safety input to the clinical development program for assigned products and development compounds
• Responsible for adequate and up to date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents
• Ensure, in collaboration with Regulatory Affairs labeling team an accurate representation and communication of the safety profile of assigned products and development compounds
• Responsible for responses to inquiries from regulatory authorities on safety issues
• Provide integrated safety input into all regulatory documents where required
• 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
• Perform the medical review of all adverse event reports for seriousness, expectedness and causality
• Assist Scientists with medical opinion on obtaining follow-up information for individual cases.
• Participate in review of scientific literature: identify case reports that meet criteria for entry into the safety database; identify relevant safety articles / references involving the active ingredients of marketed products and products in development; and create literature summary sections to be included in PSURs and other required reports.
• Ensure communication of all safety issues that may impact the benefit-risk profile of assigned products/development compounds to Senior GDS management including making presentations to the Independent Safety Review Committee
• M.D. or D.O. and at least 5 years of experience in pharmaceutical industry within Drug safety/Pharmacovigilance with both investigational and marketed products
• At least 3 years of experience with aggregate reporting, safety surveillance, signal management and/or Risk management
• Knowledge and understanding of national and international PV and regulatory guidelines
• MBA or MPH (Masters of Public Health) is a plus
• At least 2 years of Clinical Patient Care experience preferred
• Presenting drug safety topics for regulatory authorities or at conventions, meetings, etc.Product defense before a national or international regulatory authority a plus
• Drug safety database knowledge preferred
• Microsoft Word, Excel, Powerpoint, Outlook, and Adobe Acrobat
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