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Mirum Pharmaceuticals, a biopharmaceutical company focused on rare disease treatments, seeks a Senior Vice President of Drug Safety and Pharmacovigilance to lead the department's infrastructure and operations across clinical development and commercial products. This role provides strategic leadership and management oversight of the global pharmacovigilance system, ensuring compliance with worldwide regulatory requirements and safety standards.
Key responsibilities include: overseeing the global PV system for regulatory compliance; developing organizational strategy, goals, and objectives for the department; maintaining awareness of emerging safety concerns and communicating with competent authorities; managing all medical safety aspects of clinical development and post-market surveillance; directing commercial safety reporting for US, EU, and international territories; managing, mentoring, and developing staff to build future department capabilities; leading safety signal assessments and validations in partnership with clinical development; communicating critical safety information to executive stakeholders; participating in health authority interactions and inspections; overseeing Drug Safety Committees and core safety information; reviewing safety components of protocols, investigator brochures, clinical study reports, and regulatory submissions; overseeing periodic aggregate and safety reports; performing benefit-risk assessments; ensuring compliance and inspection readiness; and supporting business opportunity evaluations.
The ideal candidate holds an MD, PharmD, or equivalent degree with 15+ years of pharmacovigilance experience, including at least 5 years of department management. Required expertise includes team building, risk management strategies, signal detection, global PV requirements, vendor oversight, regulatory inspection experience, and knowledge of global regulatory requirements for product approval. Strong business acumen, cross-functional collaboration skills, excellent written and verbal communication, strategic and organizational capabilities, and the ability to work autonomously in a fast-paced environment are essential.
