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Regulatory Officer – Safety

Kampala, Uganda * Full-time
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The National Drug Authority

Category: Administration Total Positions: Location: Kampala, Uganda Full-time Salary: Not Mentioned Posted 1 year ago
Please take note of the eligibility requirements before submission: Vacancies One (1) Salary Scale NDA F1 Directorate Product Safety – CAPACITY 2023 Grant Reports to Manager Clinical Trials Direct Reports N/A Duration 2 Years (May 2025 – April 2027) Location Head Office
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KEY DUTIES AND RESPONSIBILITIES
• .1 Review clinical trial applications and submissions. To achieve this, the job holder will: • (a) Carry out qualitative scientific assessment of the applications, coming up with an evaluation report and communicating all the findings to the principal investigators. • (b) Review safety information arising out of the studies and providing responses to such information • .2 Review of Serious Adverse Events and compilation of safety summary reports for trend analyses. • .3 Inspection of clinical trial sites for compliance to the conditions of the clinical trial certificate and participate in writing GCP inspection and trip reports • .4 Participate in the development of professional guidelines, manuals, standard operating procedures and internal documents related to clinical trial oversight • 3.5 Participate in training/workshops, seminars and retreats as required or requested, for capacity building. These may be intra- or inter-directorate, regional or international. • .6 Attend internal or external technical meetings as required or requested • .7 Undertake any other responsibilities, tasks or activities as reasonably required as the above is given as a broad range of duties and is not intended to be complete description of all tasks.
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QUALIFICATIONS / SKILLS
• Bachelor’s degree in Medicine and Bachelor of Surgery (MBChB,) from an accredited institution. • Minimum Experience: • A minimum of 2 years of post-graduation experience and active involvement in a clinical setting • Familiarity with Good Clinical Practice (GCP) guidelines and other relevant regulatory standards • Ability to critically evaluate clinical data and provide insightful contributions related to patient safety monitoring • Strong verbal and written communication skills, with the ability to effectively collaborate with multidisciplinary teams. Experience in mentoring or supervising junior medical staff is an advantage. • Funding: • This position is supported by CAPACITY 2023 project (Reference: 101145599) granted by the European Union through Horizon Europe HORIZON-JU-GH-EDCTP3-2023-01-05.
HOW TO APPLY
Please submit a cover letter, copies of your academic qualifications together with your Curriculum Vitae (CV) not later than 5:00pm on Tuesday 22nd April 2025. PLEASE DELIVER YOUR APPLICATIONS TO THE REGISTRY. Your application should be addressed to the Director Human Resources and Administration, National Drug Authority, NDA Tower, Plot 93 Buganda Road
Deadline: Expired
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