Senior Pharmacovigilance Specialist

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

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Qualification

• BS / MS / Doctorate in Pharmacy, Nursing or related healthcare discipline

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Experience

• Minimum 3 years in Pharmacovigilance or Materiovigilance

• Prior experience in ICSR or device event review preferred

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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

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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

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