Pharmacovigilance and Market Surveillance Special Services Agreement Officer

Job Posting Organization:
The job posting organization is the National Department of Health (NDOH) of Papua New Guinea, specifically through its Pharmaceutical Services Standards Branch (PSSB). The NDOH is responsible for overseeing the health system in Papua New Guinea, ensuring that health services are delivered effectively and efficiently. The PSSB operates under the Medicines & Cosmetics Act (1999) and its Regulations (2002), guided by the National Medicines Policy (2014). The organization plays a crucial role in regulating medicines and medical products, ensuring their safety, efficacy, and quality. As a member of the WHO International Drug Monitoring Programme, the NDOH is committed to strengthening its national regulatory systems and fulfilling its international obligations. The PSSB is involved in various initiatives to enhance its regulatory functions, including pharmacovigilance and market surveillance, which are essential for public health protection.

Job Overview:
The Pharmacovigilance and Market Surveillance Special Services Agreement Officer will be responsible for providing dedicated technical capacity to the Pharmaceutical Services Standards Branch (PSSB) of the National Department of Health in Papua New Guinea. This position is critical for restoring, operationalizing, and sustaining the country's post-market regulatory functions, which include pharmacovigilance, market surveillance and control, and coordination of the Medical Supplies Strategic Plan (MSSP) 2026–203

• The officer will work under the direct supervision of the Manager of PSSB and will be tasked with ensuring that PNG meets its national regulatory obligations and international commitments as a Full Member of the WHO International Drug Monitoring Programme. The role encompasses a variety of responsibilities, including the collection and assessment of adverse drug reactions, coordination of market surveillance activities, and the development of regulatory guidelines and training materials. The officer will also play a key role in integrating pharmacovigilance and market surveillance findings into the broader health system, thereby enhancing the quality and safety of medicines available to the population.

Duties and Responsibilities:
The duties and responsibilities of the Pharmacovigilance and Market Surveillance SSA Officer include:

• Pharmacovigilance (PV): - Receive, assess for quality and completeness, register, and follow up on Individual Case Safety Reports (ICSRs). - Apply MedDRA coding and WHO Drug Dictionary standards. - Enter Adverse Drug Reaction (ADR) reports into VigiFlow and maintain data integrity in VigiBase. - Conduct systematic causality assessments using WHO-UMC methodology and coordinate National PV Expert Committee reviews. - Draft and disseminate medicine safety circulars and integrate safety alerts from various regulatory agencies into national communications. - Finalize national Pharmacovigilance Guidelines and develop an implementation strategy. - Fulfill PNG’s obligations as a Full Member of the WHO International Drug Monitoring Programme, including regular VigiBase submissions and annual reporting.
• Market Surveillance and Control (MSC): - Coordinate PNG’s reporting obligations under the WHO Global Surveillance and Monitoring System (GSMS) for substandard and falsified medical products. - Support investigations of substandard, falsified, or recalled medicines identified through field reports or GSMS alerts. - Manage medicine recall procedures and maintain the recall register. - Consolidate PV and MSC data to produce integrated regulatory intelligence reports for PSSB leadership.
• Institutional Strengthening: - Contribute to GBT CAPA Plan deliverables and updates arising from the 2024 WHO assessment. - Drive completion of Medicines, Therapeutics and Control (MTC), PV, and Recall Guidelines to internationally recognized standards. - Deliver structured training workshops to provincial health authority pharmaceutical inspectors and focal points. - Coordinate PSSB monthly education sessions and mentor intern pharmacists.
• MSSP 2026–2030 Coordination: - Serve as the designated PSSB liaison between the MSSP 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 for PSSB leadership.
• Perform other tasks as assigned by PSSB management and WHO in support of post-market regulatory operations.

Required Qualifications:
The required qualifications for the Pharmacovigilance and Market Surveillance SSA Officer position include: - Essential: A university degree in Pharmacy, Pharmaceutical Sciences, Medicine, Nursing, Public Health, or another health-related field from a recognized institution. - Desirable: Postgraduate training or certification in Pharmacovigilance, Regulatory Affairs, Public Health, Epidemiology, or a related field. - Knowledge of pharmacovigilance principles and medicines safety monitoring, as well as pharmaceutical regulatory requirements and post-marketing surveillance, is essential. Strong analytical and report-writing skills are also required, along with proficiency in Microsoft Office applications and pharmacovigilance data management systems.

Educational Background:
The educational background needed for this position includes a university degree in a relevant field such as Pharmacy, Pharmaceutical Sciences, Medicine, Nursing, Public Health, or another health-related discipline from a recognized institution. Additionally, postgraduate training or certification in Pharmacovigilance, Regulatory Affairs, Public Health, Epidemiology, or a related field is desirable, as it would enhance the candidate's understanding and capabilities in the role.

Experience:
The level of experience needed for the Pharmacovigilance and Market Surveillance SSA Officer position is as follows: - Essential: A minimum of 2–5 years of relevant professional experience in pharmacovigilance, pharmaceutical regulation, medicines safety monitoring, public health programmes, or related areas. Candidates should have experience in collecting, reviewing, and analyzing adverse events following the use of medicines and vaccines, as well as experience in data management, report writing, and stakeholder coordination. - Desirable: Experience working with government health authorities, regulatory agencies, WHO, UN agencies, or international organizations is preferred. Familiarity with pharmacovigilance databases and medicines regulatory systems, including VigiFlow and VigiBase, is also advantageous. Experience in training health workers and conducting surveillance activities is a plus.

Languages:
The mandatory language requirement for this position is excellent knowledge of English, both written and spoken. This proficiency is essential for effective communication and reporting within the role. While not explicitly stated, additional language skills may be beneficial, particularly if they relate to the local context or the populations served by the health system.

Additional Notes:
Additional notes regarding the position include: - 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, but the SSA Officer may be required to travel within Port Moresby and to provinces for training delivery, stakeholder engagement, and supervision activities. International travel may also be necessary for WHO training or reporting obligations. - 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 funds.