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Role & Responsibilities
Ensure high quality and regulatory-compliant case processing by vendors
Perform quality review of ICSRs and device event reports
Review and update vendor SOPs and working procedures
Monitor weekly and monthly quality data and identify training needs
Review AE/SAE and device event reports for pre and post-marketed products
Clarify medical issues, revise MedDRA coding and ensure accurate narratives
Coordinate with vendors and internal medical teams for case resolution
Support audits, inspections, CAPA documentation and vendor oversight
Maintain vigilance documentation and archival processes
Train and guide vendor vigilance staff
Implement process improvements and corrective actions
Qualification
BS / MS / Doctorate in Pharmacy, Nursing or related healthcare discipline
Experience
Minimum 3 years in Pharmacovigilance or Materiovigilance
Prior experience in ICSR or device event review preferred
Skills
Strong knowledge of global PV & MV regulations
Experience with safety databases (LSMV, CATSWeb preferred)
Excellent communication and interpersonal skills
High attention to detail and strong organizational skills
Ability to work cross-functionally and manage workflow priorities
About the Company
A global healthcare organization operating within Global Pharmacovigilance & Risk Management, focused on regulatory-compliant safety surveillance, risk management and medical device vigilance across international markets