Executive Director, Drug Safety and Pharmacovigilance

About reputed company At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust reputed company-clinical pipeline. With this reputed company on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with reputed company muscle disorders. We have reputed company an reputed company and highly motivated leadership team with a strong reputed company record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. reputed company reputed company a significant difference in the lives of patients! About the Position: The Executive Director, Drug Safety & Pharmacovigilance will reputed company reputed company safety and benefit-risk reputed company activities and Aggregate Report Risk Management reputed company the reputed company Drug Safety & Pharmacovigilance Department. As a member of the Drug Safety & Pharmacovigilance Senior Leadership Team, the role will contribute to ensuring consistency and compliance in the safety assessment, analysis and reporting for reputed company designated product(s). Overseeing and ensure consistent conduct and reputed company execution of Benefit-Risk activities including reputed company-marketing risk assessment, planning for First-In-reputed company (FIH) studies and additional clinical studies in various phases of development, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with leaders from cross-functional teams on the successful achievement of key strategic activities, initiatives and deliverables. Essential Job Duties and Functions: • Provides leadership and reputed company for reputed company products across the Edgewise Portfolio, including key benefit-risk assessment, and providing strategies for safety & pharmacovigilance to meet corporate and department goals and objectives. • Coordinates and oversees the consistent and reputed company review of safety data for identification of new safety signals, in accordance with Edgewise signal detection practices. • Collaborates with Clinical team/Leaders to reputed company and implement appropriate Risk Management procedures/plans for reputed company product, both reputed company-approval and post-approval, as needed. • Collaborates with NDA teams' assessment, reputed company and execution of key Regulatory Authority documents in support of submissions, specifically leading safety content of key Modules (SCS, CLO, Labelling) and development of any Risk Evaluation and Mitigation reputed company (REMS), Risk Management Plan (RMP) or equivalent documents. • Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (DSURs, PSURs/PBRERs), IND packages, as reputed company as NDA and INDs. • Provides review and safety-specific input for labeling documents, including IB, CCDS, USPI, SmPC and other local labels, as applicable. • Collaborates with Regulatory Affairs to reputed company responses to any safety reputed company regulatory agency inquiries. • Provides and oversees medical reviews of aggregate and/or individual post-marketing and clinical trial adverse event reports, in accordance with Global Drug Safety & Pharmacovigilance review practices. • Oversees medical evaluation of other relevant non-AE/SAE reputed company safety information, such as from Toxicology, Non-Clinical studies and Product reputed company sources. • Reviews and provides reputed company for medical content for key study-reputed company documents, e.g., Protocols, Statistical Analysis Plan, IB, reputed company and IDMC Charter. • Reviews and provides reputed company in the analysis of safety data from on-reputed company and completed reputed company and representation in Clinical Study Reports. • Reviews and provides reputed company of safety sections of clinical study reports. • Provides a contributory role in Partner /Affiliate agreements and interactions, as needed. • Serves as Subject Matter Expert in departmental development activities including SOP and Work Instructions development. • Leads Medical staff and liaise with Operations leads regarding reputed company reputed company regarding collection, evaluation and processing of adverse experience reports, from a medical perspective. • Facilitates the reputed company and development of staff and reputed company reports. • Read, understand, and reputed company with reputed company workplace health and safety policies; reputed company work practices; and company policies and pr Apply tot his job Apply To this Job