Global PV Risk Minimization Physician
Core
Lead post-marketing safety activities and risk minimization for Galderma's Injectable Aesthetics medical devices, focusing on dermal fillers and biostimulators.
Role type
Senior Global Pharmacovigilance Physician (Medical Devices)
Builds
Product risk management files, safety reports (PSURs, IFUs), and global risk minimization strategies for aesthetic medical devices.
Domain
Medical Devices / Pharmacovigilance / Aesthetics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical expertise in Class III medical devices, device vigilance knowledge, global stakeholder management, signal detection, safety surveillance, benefit-risk assessment, regulatory compliance, epidemiology, statistics, project leadership
Preferred skills
Qualifications in Clinical Pharmacology, Pharmaco/materio-vigilance, Drug Safety, Public Health, Epidemiology, or Biomedical Engineering, experience with Notified Bodies and Health Authorities in US/EU
Technologies
None stated
Responsibilities
Conduct medical review of incident reports and evaluate emerging safety data; Lead scientific review of safety information in IFUs, PSURs, and aggregate safety reports; Develop and maintain product risk management files; Coordinate global risk minimization activities; Support responses to Health Authorities and contribute to regulatory submissions; Partner with Clinical Development, Medical Affairs, and Regulatory Affairs on safety assessments
Seniority
Senior, hands-on IC with global leadership