Admin Officer – Clinical Trials (Serious Adverse Events (SAES)

South African Health Products Regulatory Authority; Pretoria; On-site; ZAR 240 000 - 360 000; Full time

Job summary

A leading health authority in Pretoria is seeking an Admin Officer for Clinical Trials. The role involves screening and supporting Serious Adverse Events (SAEs), managing data, and handling stakeholder queries. Ideal candidates will have relevant qualifications and experience in office administration and regulatory processes.

Qualifications

• Matric certificate and post-matric certification/Diploma required.
• One to two years of experience with MS Office and office administration.

Responsibilities

• Provide administrative support for SAEs reported during clinical trials.
• Manage SAE data in VigiFlow database and assist in extracting information.
• Attend to stakeholder queries on SAEs and support safety reporting.

Skills

MS Office

Office Administration

Regulatory Knowledge

Education

Matric Certificate

Post-Matric Certification/Diploma

Degree in Health Sciences

Job description

Job Title: Admin Officer – Clinical Trials (Serious Adverse Events (SAEs))

Location: Gauteng, Pretoria

Deadline: June 15, 2025

Requirements

• Matric certificate and post-matric certification/Diploma with training/certification as a qualified post-basic Pharmacist Assistant or degree in health sciences, registered with a professional body. Basic pharmaceutical knowledge is required.

Experience

• One to two years of experience with MS Office (Excel and Word), email/Outlook, office administration, and filing. Regulatory experience is an advantage.

Duties

1. Screen and provide administrative support for SAEs reported during the clinical trial process: review SAE reports for completeness, upload correspondence and related documentation following SOPs, save on shared drive, and update SAE spreadsheets/tracker. Allocate SAE correspondence to technical staff and monitor report receipt.
2. Manage SAE data in VigiFlow database: ensure all relevant fields are filled, MedDRA terminologies are correctly indicated, and assist in extracting information related to clinical trials based on trends.
3. Attend to stakeholder queries on SAEs and assist with safety reporting activities: identify reports with deficiencies, request missing information, prepare and send correspondence, and escalate queries as needed. Support internal and external audit responses.
4. Perform administrative and management tasks as required.