Regional PV Operations Leader (APAC & MEA)

Harold Consultancy; Selangor; On-site; MYR 180,000 - 210,000; Full time

Job summary

Harold Consultancy seeks a Regional Pharmacovigilance Specialist to manage PV operations across Asia-Pacific and the Middle East. You will ensure compliance, operational excellence, and timely safety execution under the Senior Manager, PV.

The role involves end-to-end ICSR processes, vendor oversight, reconciliation, KPI tracking, and PV documentation. You will collaborate with internal teams and partners to maintain inspection readiness and drive continuous improvement.

Qualifications

• Bachelor’s degree in a life sciences or healthcare field is required.
• Hands-on experience in pharmacovigilance operations and case processing.
• Experience with ICSR management and regulatory reporting.
• Familiarity with PV systems and safety databases (Argus/ARISg).
• Knowledge of global/regional PV regulations and quality systems.

Responsibilities

• Execute daily PV operational activities to maintain a compliant regional PV system.
• Oversee end-to-end ICSR processes, including intake, processing, follow-up, quality review, and regulatory submission.

Skills

Case management

Vendor oversight

Reconciliation

Quality systems

Education

Bachelor's degree in Pharmacy, Nursing, Biology, Life Sciences, or related

Tools

Argus Safety

ARISg

Job description

Harold Consultancy seeks a Regional Pharmacovigilance Specialist to manage PV operations across Asia-Pacific and the Middle East. You will ensure compliance, operational excellence, and timely safety execution under the Senior Manager, PV.

The role involves end-to-end ICSR processes, vendor oversight, reconciliation, KPI tracking, and PV documentation. You will collaborate with internal teams and partners to maintain inspection readiness and drive continuous improvement.