Regulatory Officer – Safety

Perform clinical trials’ oversight functions related to improving safety management at the National Drug Authority.

Qualifications & Experience:

• Essential:
  

  • Bachelor of Medicine & Surgery (MBChB) from an accredited institution.
    
  • 2+ years of post-graduation clinical experience.
    
  • Knowledge of GCP guidelines and regulatory standards.
    
  • Strong analytical and communication skills.
    
• Advantage: Experience in mentoring junior staff.
  

3.1  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

3.2   Review of Serious Adverse Events and compilation of safety summary reports for trend analyses.

3.3   Inspection of clinical trial sites for compliance to the conditions of the clinical trial certificate and participate in writing GCP inspection and trip reports

3.4   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.

3.6   Attend internal or external technical meetings as required or requested

3.7   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.