Special Service Agreement - Pharmacovigilance and Market Surveillance

The SSA Officer will provide dedicated technical capacity to the Pharmaceutical Services Standards Branch (PSSB) to restore, operationalize, and sustain Papua New Guinea’s post-market regulatory functions including pharmacovigilance, market surveillance and control, institutional strengthening, and coordination of the Medical Supplies Strategic Plan 2026–2030. The role supports PNG’s national regulatory obligations and international commitments as a member of the WHO International Drug Monitoring Programme.

Responsibilities

• Receive, assess for quality and completeness, register, and follow up Individual Case Safety Reports (ICSRs); apply MedDRA coding and WHO Drug Dictionary standards.
• Enter ADR reports into VigiFlow; maintain data integrity in VigiBase; manage ongoing MedDRA and WHO Drug Dictionary updates.
• Conduct systematic causality assessments using WHO-UMC methodology; coordinate National PV Expert Committee reviews as required.
• Draft and disseminate medicine safety circulars; integrate safety alerts from TGA, WHO, and other regulatory agencies into national communications.
• Finalise national Pharmacovigilance Guidelines and develop an implementation strategy; advance PV-related deliverables under the 2024 WHO Global Benchmarking Tool (GBT) Corrective Action and Preventative Action (CAPA) Plan.
• Fulfil PNG’s obligations as the 131st Full Member of the WHO International Drug Monitoring Programme (IDMP), including regular VigiBase submissions and annual reporting.
• Coordinate PNG’s reporting obligations under the WHO Global Surveillance and Monitoring System (GSMS) for substandard and falsified medical products; submit timely alerts.
• Support investigation of substandard, falsified, or recalled medicines identified through field reports, complaints, or GSMS alerts; liaise with the National Medicines Procurement Authority (NMPA) and relevant stakeholders.
• Support management of medicine recall procedures; maintain the recall register; draft stakeholder communications; coordinate responses to WHO and manufacturer alerts.
• Consolidate PV and MSC data to produce integrated regulatory intelligence reports for PSSB leadership and NDOH Senior Executive Management.
• Contribute to GBT CAPA Plan deliverables and Institutional Development Plan (IDP) updates arising from the 2024 WHO assessment.
• Drive completion of Medicines, Therapeutics and Control (MTC), PV, and Recall Guidelines to internationally recognised standards; develop training packages for all finalised guidelines.
• Deliver structured training workshops to provincial health authority (PHA) pharmaceutical inspectors and focal points; produce provincial readiness assessments and establish feedback loops from PHAs to PSSB.
• Coordinate PSSB monthly education sessions (Brown Bag); mentor intern pharmacists; support AMR secretariat activities.
• Serve as the designated PSSB liaison between the MSSP 2026–2030 implementation team and PV/MSC functions; ensure ADR signals and market surveillance findings are systematically fed into MSSP supply chain quality reporting and planning cycles.
• Represent PV and MSC perspectives in relevant MSSP working group meetings; flag safety and quality trends with implications for medicines procurement and supply planning.
• Consolidate PV, MSC, and MSSP-related quality data into integrated reports for PSSB leadership to support evidence-based supply planning and procurement decisions.
• Perform other tasks as assigned by PSSB management and WHO in support of post-market regulatory operations.

Requirements

• University degree in Pharmacy, Pharmaceutical Sciences, Medicine, Nursing, Public Health, or another health-related field from a recognised institution.
• Postgraduate training or certification in Pharmacovigilance, Regulatory Affairs, Public Health, Epidemiology, or a related field is desirable.
• Minimum of 2–5 years of relevant professional experience in pharmacovigilance, pharmaceutical regulation, medicines safety monitoring, public health programmes, or related areas.
• Experience in collecting, reviewing, and analysing adverse events following the use of medicines and vaccines.
• Experience in data management, report writing, and stakeholder coordination.
• Experience working with government health authorities, regulatory agencies, WHO, UN agencies, or international organisations is desirable.
• Experience with pharmacovigilance databases and medicines regulatory systems, including VigiFlow, VigiBase, or equivalent platforms is desirable.
• Experience in training health workers and conducting surveillance activities is desirable.
• Knowledge of pharmacovigilance principles and medicines safety monitoring.
• Knowledge of pharmaceutical regulatory requirements and post-marketing surveillance, including the WHO Global Surveillance and Monitoring System (GSMS) for substandard and falsified medical products.
• Strong analytical and report-writing skills, including the ability to conduct causality assessments using WHO-UMC or equivalent methodology.
• Proficiency in Microsoft Office applications and pharmacovigilance data management systems.
• Good communication and interpersonal skills; ability to work independently and collaboratively with NDOH, WHO, provincial health authorities, and other stakeholders.
• Ability to develop regulatory guidelines, training materials, and standard operating procedures to internationally recognized standards.
• Excellent knowledge of English (written and spoken).

Skills

• Pharmacovigilance
• Medicines Safety Monitoring
• Pharmaceutical Regulatory Requirements
• Adverse Event Analysis
• Data Management
• Report Writing
• Stakeholder Coordination
• Pharmacovigilance Databases
• VigiFlow
• VigiBase
• Training Health Workers
• Surveillance Activities
• Post-Marketing Surveillance
• WHO Global Surveillance and Monitoring System
• Causality Assessment
• WHO-UMC Methodology
• Microsoft Office Suite
• Regulatory Guidelines Development
• Standard Operating Procedures Implementation

Languages

English