Rxilient Medical is seeking an experienced Regional Pharmacovigilance Specialist to support the day-to-day operations of the regional Pharmacovigilance (PV) system. The role is responsible for ensuring operational excellence, regulatory compliance, and the timely execution of PV activities across Asia-Pacific and the Middle East.
The ideal candidate is a hands-on PV professional with strong operational experience in case management, vendor oversight, reconciliation, quality systems, and compliance. The successful candidate will work closely with the Senior Manager, Pharmacovigilance to ensure that all PV activities are executed efficiently, accurately, and in accordance with global and local regulatory requirements.
Specific accountabilities include:
- Perform day-to-day pharmacovigilance operational activities to support an effective and compliant regional PV system.
- Manage end-to-end Individual Case Safety Report (ICSR) activities, including case intake, processing oversight, follow-up, quality review, exchange with business partners, and regulatory reporting in accordance with applicable timelines.
- Monitor PV operational KPIs and ensure compliance with contractual, regulatory, and internal performance timelines.
- Monitor and manage PV mailboxes and ensure timely triage, assessment, and distribution of safety information.
- Coordinate routine reconciliation activities with business partners, distributors, affiliates, vendors, and internal departments, and ensure discrepancies are investigated and resolved in a timely manner.
- Coordinate literature screening activities and ensure documentation is complete and compliant.
- Maintain accurate PV operational trackers, reconciliation logs, KPI reports, inspection readiness documentation, and compliance metrics.
- Support oversight of outsourced PV vendors and business partners to ensure compliance with Safety Data Exchange Agreements (SDEAs), contractual obligations, and applicable PV requirements.
- Prepare, review, and maintain Pharmacovigilance Agreements (e.g., SDEAs), Standard Operating Procedures (SOPs), Work Instructions (WIs), forms, templates, and other PV quality documents.
- Maintain and update the Pharmacovigilance System Master File (PSMF) and other controlled PV documentation.
- Support internal audits, external audits, inspections, and CAPA implementation to ensure continuous compliance and inspection readiness.
- Coordinate PV training activities, maintain the regional PV training matrix, and ensure induction and refresher training records remain current.
- Support signal management activities, aggregate safety reports (e.g., PSURs/PBRERs, DSURs), Risk Management Plans (RMPs), and other regulatory safety deliverables, where applicable.
- Serve as the regional PV contact for internal stakeholders, distributors, vendors, and business partners regarding adverse event reporting obligations, product quality complaints with safety implications, and pharmacovigilance processes.
- Identify opportunities to improve PV operational efficiency through process optimization, digitalization, automation, and AI-enabled technologies.
- Perform other pharmacovigilance and regulatory compliance activities as assigned by the Senior Manager, Pharmacovigilance.
Qualifications/Requirements:
- Bachelor's degree in Pharmacy, Nursing, Biology or Life Sciences, or a related scientific or healthcare discipline.
- Minimum 5–7 years of pharmacovigilance experience within the pharmaceutical industry.
- Strong hands-on experience in operational pharmacovigilance, including ICSR management, case processing oversight, reconciliation activities, vendor management, and regulatory reporting.
- Experience working with safety databases such as Argus Safety, ARISg, or equivalent systems.
- Good knowledge of global and regional pharmacovigilance regulations, including FDA, EMA, ICH, CDE, and Asia-Pacific regulatory requirements.
- Experience supporting audits, inspections, CAPA management, and quality systems.
- Experience preparing or maintaining SDEAs, SOPs, PSMF, and other PV quality documentation is preferred.
- Experience working with regional business partners, distributors, and health authorities across Asia-Pacific is an advantage.
