Regional Pharmacovigilance Lead – APAC & ME Operations

Rxilient Health Pte. Ltd.

Petaling Jaya

On-site

MYR 120,000 - 180,000

Full time

5 days ago
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Job summary

Rxilient Health Pte. Ltd. seeks an experienced Regional Pharmacovigilance Specialist to support the day-to-day operation of the regional PV system across Asia-Pacific and the Middle East.

The candidate should have hands-on PV experience in case management, vendor oversight, reconciliation, quality systems, and regulatory compliance, working closely with the Senior Manager, Pharmacovigilance to ensure efficient, compliant PV activities.

Qualifications

  • Bachelor's degree in Pharmacy, Nursing, Biology or Life Sciences, or a related discipline.
  • Minimum 5–7 years of pharmacovigilance experience in the pharmaceutical industry.
  • Hands-on experience in ICSR management, case processing oversight, reconciliation activities, vendor management, and regulatory reporting.

Responsibilities

  • Perform day-to-day pharmacovigilance operational activities to support a regional PV system.
  • Manage end-to-end ICSR activities including intake, processing oversight, follow-up, quality review, and regulatory reporting.
  • Monitor PV KPIs and ensure compliance with timelines and contractual/regulatory requirements.
  • Coordinate PV training activities and maintain training records.
  • Support oversight of outsourced PV vendors and ensure SDEA/QA compliance.

Skills

ICSR management
Vendor management
Regulatory reporting
PV operations
Process improvement
Quality systems

Education

Bachelor's degree in Pharmacy or Life Sciences

Tools

Argus Safety
ARISg

Job description

Rxilient Health Pte. Ltd. seeks an experienced Regional Pharmacovigilance Specialist to support the day-to-day operation of the regional PV system across Asia-Pacific and the Middle East.

The candidate should have hands-on PV experience in case management, vendor oversight, reconciliation, quality systems, and regulatory compliance, working closely with the Senior Manager, Pharmacovigilance to ensure efficient, compliant PV activities.

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