Special Service Agreement - Pharmacovigilance And Market Surveillance, Papua New Guinea

Organizational Context

Papua New Guinea's National Department of Health (NDOH), through its Pharmaceutical Services Standards Branch (PSSB), is seeking a Pharmacovigilance and Market Surveillance Officer. This role is crucial for PNG to uphold its obligations as a medicines regulator and as a Full Member of the WHO International Drug Monitoring Programme (IDMP), ensuring safe and quality medicines.

Job Purpose

The purpose of this role is to provide dedicated technical capacity to the Pharmaceutical Services Standards Branch (PSSB) to restore, operationalize, and sustain Papua New Guinea’s post-market regulatory functions. This includes comprehensive pharmacovigilance, market surveillance and control, and institutional strengthening. The officer will also coordinate these activities with the Medical Supplies Strategic Plan 2026–2030. This position is vital for fulfilling PNG’s national regulatory obligations and its international commitments as the 131st Full Member of the WHO International Drug Monitoring Programme. The role ensures the systematic detection, assessment, understanding, and prevention of adverse effects of medicines, as well as the detection and response to substandard and falsified medical products in the PNG market, thereby safeguarding public health and ensuring the quality and safety of medicines.

Responsibilities

The SSA Officer will manage pharmacovigilance activities, including receiving, assessing, registering, and following up Individual Case Safety Reports (ICSRs), applying MedDRA coding, and entering reports into VigiFlow. They will conduct causality assessments, draft safety circulars, finalize national Pharmacovigilance Guidelines, and ensure PNG fulfills its WHO International Drug Monitoring Programme obligations. Responsibilities also cover Market Surveillance and Control, coordinating reporting to the WHO Global Surveillance and Monitoring System (GSMS) for substandard and falsified medical products, supporting investigations, and managing medicine recall procedures. The officer will consolidate PV and MSC data into regulatory intelligence reports. For institutional strengthening, the role involves contributing to GBT CAPA Plan deliverables, completing MTC, PV, and Recall Guidelines, developing training packages, and delivering workshops to provincial health authorities. They will also coordinate PSSB education sessions and mentor intern pharmacists. Finally, the officer will serve as the PSSB liaison for the Medical Supplies Strategic Plan 2026–2030, ensuring PV and MSC findings inform supply chain quality reporting and planning, representing these perspectives in working groups, and consolidating data for evidence-based procurement decisions.

Work Experience

Essential: 2–5 years of professional experience in pharmacovigilance, pharmaceutical regulation, medicines safety monitoring, or public health. This includes experience in collecting, reviewing, and analyzing adverse events, data management, report writing, and stakeholder coordination. Desirable: Experience with government health authorities, regulatory agencies, WHO, UN agencies, or international organizations, including pharmacovigilance databases (e.g., VigiFlow, VigiBase) and training health workers.

Skills

Knowledge of pharmacovigilance principles, medicines safety monitoring, and pharmaceutical regulatory requirements (including WHO GSMS). Strong analytical and report-writing skills, including causality assessments (WHO-UMC methodology). Proficiency in Microsoft Office and pharmacovigilance data management systems. Good communication and interpersonal skills, with the ability to work independently and collaboratively. Ability to develop regulatory guidelines, training materials, and SOPs.

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