Overview
This role supports the Pharmaceutical Services Standards Branch in Papua New Guinea to restore, operationalize, and sustain post-market regulatory functions, including pharmacovigilance and market surveillance, to meet national and international obligations.
Key Responsibilities
- Receive, assess, register, and follow up on Individual Case Safety Reports (ICSRs), applying MedDRA coding and WHO Drug Dictionary standards.
- Enter ADR reports into VigiFlow and maintain data integrity in VigiBase.
- Conduct systematic causality assessments and coordinate National PV Expert Committee reviews.
- Draft and disseminate medicine safety circulars and integrate safety alerts.
- Finalise national Pharmacovigilance Guidelines and develop an implementation strategy.
- Fulfil PNG’s obligations as a Full Member of the WHO International Drug Monitoring Programme.
- Coordinate PNG’s reporting obligations under the WHO Global Surveillance and Monitoring System (GSMS).
- Support investigation of substandard, falsified, or recalled medicines.
- Support management of medicine recall procedures and maintain the recall register.
- Consolidate PV and MSC data to produce integrated regulatory intelligence reports.
- Contribute to GBT CAPA Plan deliverables and Institutional Development Plan (IDP) updates.
- Drive completion of MTC, PV, and Recall Guidelines and develop training packages.
- Deliver structured training workshops to provincial health authority (PHA) pharmaceutical inspectors and focal points.
- Coordinate PSSB monthly education sessions and mentor intern pharmacists.
- Serve as the designated PSSB liaison between the MSSP 2026–2030 implementation team and PV/MSC functions.
- Represent PV and MSC perspectives in relevant MSSP working group meetings.
- Consolidate PV, MSC, and MSSP-related quality data into integrated reports.
Required Experience
- 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.
- Experience with pharmacovigilance databases and medicines regulatory systems, including VigiFlow, VigiBase, or equivalent platforms.
- Experience in training health workers and conducting surveillance activities.
Qualifications
- 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.
