Senior Director, MD Global Development Lead, Early Development
Pfizer
Medical Director, Gastrointestinal and Inflammation
Takeda
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts
Visit company websiteSalary
💰 $228,200 - $358,600 per year
Job Level
Lead
About the role
- Principal responsibilities include: Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product. Leads GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products. Represents the cross-functional program team as a product safety profile and risk mitigation expert for internal and external stakeholders. Manages cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products. Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature. Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products. Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. Ensure communication of all safety information that may impact the benefit-risk profile of assigned products to senior management. Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents. Provide patient safety input to the clinical development program for assigned products and development compounds. Manage benefit-risk profile, including authoring and updating of the benefit-risk documents, e.g., RMPs, for assigned compounds and products. Collaborate and communicate safety issues with other functional areas. Interact with Regulatory Authorities as part of a cross-functional team to submit and defend regulatory inquires, MAAs, NDAs, and BLAs. Ensure up-to-date representation of safety information in Company Core Data Sheet and Investigator Brochure.
Requirements
- M.D. or D.O. or internationally recognized equivalent, with direct clinical experience in patient care following post-graduate training and appropriate grounding and knowledge of general medicine. Board certification and licensure preferred. 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.
