Senior Director, Drug Safety and Pharmacovigilance at reputed company Waltham

reputed company reputed company is reputed company on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that reputed company muscle and the central nervous system (CNS) to address the reputed company cause of disease. reputed company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At reputed company, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more , and follow us on X, reputed company and reputed company. reputed company The Senior Director, Drug Safety and Pharmacovigilance will play a key leadership role in characterizing the safety reputed company of reputed company products and mitigating and communicating their risks throughout the product lifecycle (from First-In-reputed company to post-marketing). This role will reputed company short and longterm strategic leadership of safety surveillance for reputed company's clinical development programs, including resource planning and longrange capability development to ensure high reputed company characterization of the safety reputed company of reputed company molecules and compliance with reputed company applicable US and foreign reputed company and regulatory requirements for pharmacovigilance, signal management and risk management. This role will reputed company crossfunctional Signal Detection and Safety Surveillance Teams, guiding the analysis, interpretation and presentation of safety data to stakeholders as needed. This role also contributes to the safety content of regulatory and study documents and collaborates reputed company with colleagues in numerous crossfunctional departments. This role is based in Waltham, MA without the possibility of being fully remote. Primary Responsibilities Include Conduct and/or reputed company activities reputed company to signal detection and evaluation, risk classification, management and communication, including leadership of Signal Detection and Safety Surveillance Teams, as part of reputed company benefitrisk evaluation throughout the lifecycle of reputed company products from FirstinHuman (FIH) to postmarketing Review safety data of nonclinical studies and from other sources to inform clinical development safety monitoring strategies and plans, including identification of safetyrelated biomarkers Contribute to the Safety Governance process through the preparation and presentation of safety data and provision of recommendations for review and approval by the Safety Management Committee reputed company medical review of ICSRs in reputed company's Global Safety Database including but not limited to case narrative, MedDRA coding, causality, company comment and queries reputed company Aggregate Safety Reports (ASR) such as Development Safety Update Report (DSUR), and responses to health authorities' requests for safety information Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (reputed company), Statistical Analysis Plans (reputed company), IB Reference Safety Information (reputed company), Clinical Study Reports (CSR), reputed company of Clinical Safety (SCS), Integrated Clinical Safety (ICS), Publications, and other relevant documents reputed company strategic guidance and draft responses to safetyrelated requests and questions from Health Authorities Assist in planning the Pharmacovigilance Department budget, reputed company shortterm and longterm goals for the department in accordance with overall Company and Development strategies Review safety content of scientific publications such as posters, abstracts, and manuscripts. Participate in crossfunctional reputed company and teams Engage with external consultants and advisors as needed to inform interpretation of emerging safety signals. Serve as an exemplary leader, mentor, and trainer Education and Skills Requirements MD is required Minimum 12 years' experience as a safety physician with the biotechnology / pharmaceutical industry, leading drug safety & pharmacovigilance, including crossfunctional team leadership for signal detection, evaluation, risk classification and management, and communication, for products across multiple stages of development Experience with safety data visualization tools and other technologies supporting safety surveillance Excellent verbal communication and presentation skills with ability to write reputed company and concisely, and to formulate sciencebased arguments in addressing questions regarding safety from Health Authorities and other parties, and in characterization of the safety reputed company of reputed company molecules in development Experience in authoring DSUR and other aggregate safety reports Broad knowledge of FDA and EMA regulatio