Admin Officer – Clinical Trials (Serious Adverse Events (SAES) needed at South African Health Products Regulatory Authority

REQUIREMENTS:

•  Matric certificate and post-matric certification/Diploma with Training/Certification as a qualified post-basic Pharmacist Assistant or degree in health sciences and registration with a Professional Body. Basic Pharmaceutical knowledge is a requirement.

 
EXPERIENCE:  

• One (1) to two (2) years of experience with MS Office (Excel and Word), email/Outlook, office administration and filing. Regulatory experience will be an added advantage. 

DUTIES:

• Screen and admin support of SAEs reported during the clinical trial process: Quality admin screen SAE reports for completion. Upload SAE correspondence and related documentation following standard operating procedures (SOP) and save on the shared drive. Capture the report on the SAE spreadsheet/tracker. Allocate SAE correspondence to technical staff and monitor reports received. Allocate correspondence to technical staff. 
• SAE data management – VigiFlow database and assist with data information: Capture the SAE reports on VigiFlow database – ensure all the relevant fields are filled and all MedDRA terminologies are properly indicated for useful data. Assist in extracting information relating to a clinical trial in question or a sample, as determined by the Assessor from time to time, based on trends.
•  Attend stakeholder queries on SAEs and assist with other activities related to safety reporting: Identify SAEs reports with deficiencies and request the missing information. Type the letters on Serious Adverse Events Reports as applicable and mailing correspondences to applicants. Attend to queries relating to SAEs or escalate to the responsible Assessor. Assist in attending to internal and external audit queries.