Sr Mgr Regulatory Compliance - Medical Events, Vigilance & AE Case Reporting
Core
Lead global medical device vigilance and pharmacovigilance activities, including adverse event management, regulatory reporting, and safety signal detection for drugs, biologics, combination products, and consumer products.
Role type
Senior Manager, Regulatory Compliance (Medical Events & Pharmacovigilance)
Builds
Global safety reporting systems and compliance programs for medical devices and pharmaceuticals
Domain
Healthcare / Life Sciences / Regulatory Affairs
Required skills
Medical device vigilance management, Pharmacovigilance operations, Adverse event case management, Regulatory reporting (FDA/global), Safety coding (MedDRA/IMDRF), Risk assessment, Cross-functional leadership, Audit/inspection support, Team management, Process improvement
Preferred skills
RN or PharmD/RPh credential, MedDRA coding certification, Combination-product safety reporting experience
Technologies
MedDRA, IMDRF, Microsoft Word, Microsoft Excel
Responsibilities
Manage medical device vigilance program and personnel; oversee drug/biologic pharmacovigilance activities including ICSR and ADR reporting; manage safety coding and adverse event reconciliation; support regulatory inspections and audits; provide training on safety reporting; lead process improvements and policy implementation.
Seniority
Senior, hands-on IC with management responsibilities