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

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Background Papua New Guinea's National Department of Health (NDOH), through its Pharmaceutical Services Standards Branch (PSSB), seeks to engage a Pharmacovigilance and Market Surveillance Special Services Agreement (SSA) Officer. This position is essential to sustaining and advancing PNG's obligations as a medicines regulator and as the 131st Full Member of the WHO International Drug Monitoring Programme (IDMP). 1.1 National Regulatory Framework PSSB exercises NDOH's statutory mandate as PNG's National Regulatory Authority (NRA) for medicines and medical products, under the authority of the Medicines & Cosmetics Act (1999) and its Regulations (2002) and guided by the National Medicines Policy (2014). At the international level, PNG's NRA responsibilities are reinforced by World Health Assembly Resolution 67.20, which calls upon all Member States to strengthen their national regulatory systems to ensure that medicines available to their populations are safe, effective, and of assured quality. The WHO Global Benchmarking Tool (GBT) provides the internationally recognised framework for assessing NRA maturity. PNG has undertaken GBT self-assessments in 2016 and 2024, with the 2024 assessment producing a Corrective Action and Preventative Action (CAPA) Plan that identifies specific, time-bound improvements required across PSSB's regulatory functions — including pharmacovigilance and post-market surveillance. 1.2 The Pharmacovigilance Imperative Pharmacovigilance (PV) — the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects of medicines — is a core NRA competency and a binding international obligation. As a Full Member of the WHO International Drug Monitoring Programme, PNG is required to systematically collect, assess, and report Individual Case Safety Reports (ICSRs) to the global VigiBase database, maintained by the Uppsala Monitoring Centre (UMC). To date, this function has been operationally dependent upon a single officer engaged through external project funding (IMR/PAVE). The termination of that arrangement in March 2026 has left PSSB without dedicated PV capacity at a time when the workload is growing and international reporting cycles cannot be paused. 1.3 The Market Surveillance and Control Opportunity Beyond PV, PSSB is responsible for Market Surveillance and Control (MSC) — encompassing the detection and response to substandard and falsified (SF) medical products in the PNG market. The WHO Global Surveillance and Monitoring System (GSMS) provides the international infrastructure for reporting and responding to SF product alerts. PNG's participation in GSMS is both a regulatory obligation and a public health protection measure. At present, PSSB's MSC function lacks dedicated support for GSMS reporting, recall coordination, and post-market intelligence synthesis. The proposed SSA engagement offers a pragmatic and cost-effective opportunity to integrate MSC responsibilities into this role — creating a comprehensive post-market regulatory officer whose mandate spans both adverse drug reaction monitoring and product quality surveillance. 1.4 Linkage to the Medical Supplies Strategic Plan 2026–2030 The officer will serve as PSSB's designated coordination focal point linking post-market regulatory intelligence to the implementation of the Medical Supplies Strategic Plan (MSSP) 2026–2030, ensuring that PV and MSC findings actively inform medicines supply planning, quality assurance, and medicines management objectives across the health system.

Objective of the Position

To provide dedicated technical capacity to the Pharmaceutical Services Standards Branch (PSSB) to restore, operationalize, and sustain PNG’s post-market regulatory functions — encompassing pharmacovigilance, market surveillance and control, institutional strengthening, and MSSP 2026–2030 coordination — in fulfilment of PNG’s national regulatory obligations and its international commitments as the 131st Full Member of the WHO International Drug Monitoring Programme.

Summary of Assigned Duties

Under the direct supervision of the Manager, Pharmaceutical Services Standards Branch (PSSB), and the technical oversight of the WHO Country Office PNG as the contracting authority, the SSA Officer will carry out the following duties across four integrated functional domains:

Pharmacovigilance (PV)

1. Receive, assess for quality and completeness, register, and follow up Individual Case Safety Reports (ICSRs); apply MedDRA coding and WHO Drug Dictionary standards.
2. Enter ADR reports into VigiFlow; maintain data integrity in VigiBase; manage ongoing MedDRA and WHO Drug Dictionary updates.
3. Conduct systematic causality assessments using WHO-UMC methodology; coordinate National PV Expert Committee reviews as required.
4. Draft and disseminate medicine safety circulars; integrate safety alerts from TGA, WHO, and other regulatory agencies into national communications.
5. 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.
6. Fulfil PNG’s obligations as the 131st Full Member of the WHO International Drug Monitoring Programme (IDMP), including regular VigiBase submissions and annual reporting.

Market Surveillance and Control (MSC)

1. Coordinate PNG’s reporting obligations under the WHO Global Surveillance and Monitoring System (GSMS) for substandard and falsified medical products; submit timely alerts.
2. 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.
3. Support management of medicine recall procedures; maintain the recall register; draft stakeholder communications; coordinate responses to WHO and manufacturer alerts.
4. Consolidate PV and MSC data to produce integrated regulatory intelligence reports for PSSB leadership and NDOH Senior Executive Management.

Institutional Strengthening

1. Contribute to GBT CAPA Plan deliverables and Institutional Development Plan (IDP) updates arising from the 2024 WHO assessment.
2. Drive completion of Medicines, Therapeutics and Control (MTC), PV, and Recall Guidelines to internationally recognised standards; develop training packages for all finalised guidelines.
3. 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.
4. Coordinate PSSB monthly education sessions (Brown Bag); mentor intern pharmacists; support AMR secretariat activities.

MSSP 2026–2030 Coordination

1. 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.
2. Represent PV and MSC perspectives in relevant MSSP working group meetings; flag safety and quality trends with implications for medicines procurement and supply planning.
3. Consolidate PV, MSC, and MSSP-related quality data into integrated reports for PSSB leadership to support evidence-based supply planning and procurement decisions.
4. Perform other tasks as assigned by PSSB management and WHO in support of post-market regulatory operations.

Expected Outputs

• ADR reports current in VigiFlow; VigiBase submissions up to date; National Pharmacovigilance Guidelines — final draft submitted for PSSB endorsement; Annual PV Report submitted to WHO-IDMP.
• GSMS registration confirmed; at least one (1) quarterly MSC situational report and one (1) GSMS quarterly report submitted to WHO; Recall Guideline finalised and endorsed; recall register established and maintained; annual cross-system intelligence report finalised.
• MTC, PV, and Recall Guidelines finalised; training packages developed and structured workshops delivered to PHA pharmaceutical inspectors and focal points; GBT CAPA Plan milestones reported to WHO quarterly; IDP updated; PHA provincial readiness assessment completed.
• MSSP 2026–2030 coordination role initiated; at least one (1) integrated PV-MSC-MSSP intelligence report submitted to PSSB leadership; MSSP working group updated with PV and MSC regulatory intelligence; monthly progress reports submitted throughout the assignment; transition plan and all SOPs documented for institutional continuity by end of assignment.

Qualifications, experience, skills and languages

Educational Qualifications

Essential: University degree in Pharmacy, Pharmaceutical Sciences, Medicine, Nursing, Public Health, or another health-related field from a recognised institution.
Desirable: Postgraduate training or certification in Pharmacovigilance, Regulatory Affairs, Public Health, Epidemiology, or a related field.

Experience

Essential: 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.
Desirable: Experience working with government health authorities, regulatory agencies, WHO, UN agencies, or international organisations.
Experience with pharmacovigilance databases and medicines regulatory systems, including VigiFlow, VigiBase, or equivalent platforms.
Experience in training health workers and conducting surveillance activities.

Skills and Knowledge

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.

Languages

Essential: Excellent knowledge of English (written and spoken).

Duty Station / Location

The position will be based at the Pharmaceutical Services Standards Branch (PSSB), National Department of Health, Port Moresby, Papua New Guinea.

Travel Requirements

The assignment is primarily office-based. The SSA Officer may be required to travel within Port Moresby and to provinces for training delivery, stakeholder engagement, and PHA supervision activities. International travel may be required for WHO training or reporting obligations as applicable.

Remuneration and Duration

The monthly remuneration for this position is PGK 9,736 payable monthly.

The assignment is expected to run for a total of twelve (12) months from the date of contract signing, subject to satisfactory performance and availability of fund.