Summary
Date Posted: Monday, April 04, 2022 , Base Salary: Not Disclosed

JOB DETAILS:
Vacancies: One (1)
Department: Directorate of Product Safety
Reports to: Director Product Safety
Direct reports: Principal Regulatory Officer / Regulatory Officers
Salary scale: NDA D
Location: Head Office

Job Purpose:
To promote effective regulation of clinical trials to meet scientifically sound objectives, generation of quality data for regulatory decision-making and protection of participants’ rights and safety.

Duties and Responsibilities:
• Advise the Director on all matters pertaining to regulation of clinical trials regularly.
• Develop a strategy for effective oversight of clinical trials processes.
• Supervise and manage the resources of the clinical trials unit including staff development, preparation and execution of budgets and work plans for all clinical trial activities.
• Coordinate and facilitate processing of clinical trial applications.
• Develop and maintain good relations with principal investigators.
• Maintain and update a register of clinical trials authorized in the country.
• Provide regular reporting to the director on the status of clinical trial operations.
• Coordinate the development and review of regulations, guidelines, training manuals, Standard Operating Procedures, IEC materials and performance standards.
• Provide responses to client inquiries on matters related to clinical trials.
• Liaise with teams from Imports and Exports, PV and Product Registration on the safety, efficacy and quality of investigational products.
• Conduct evaluation of Serious Adverse Events and other safety reports and recommend safety measures for ongoing clinical trials.
• Alert researchers/principal investigators on new risks of investigational medicinal products.
• Provide accurate technical information to all relevant stakeholders and the general public on investigational medicinal products
• Perform any other responsibilities, tasks or activities assigned by the Supervisor from time to time.

Education:
• Bachelor of Pharmacy, Pharmaceutical Science, MBCHB, Bachelor of Dental Surgery, BSN/BNS (Nursing Sciences) and;
• Masters’ in Pharmacy, Health Sciences, Pharmaceutical Sciences, Regulatory Sciences, Public Health.

Experience:
• Eight (8) years’ experience in regulation, a minimum of five (5) years of management/supervisory experience.

Key Competencies
• Proficiency in computer applications especially MS office packages.
• High level of Integrity.
• Keen attention to detail.
• Good communication and interpersonal skills.

Work Hours: 8

Experience in Months: 96

Level of Education: Bachelor Degree

Job application procedure
Please submit a cover letter, copies of your academic qualifications together with your Curriculum Vitae (CV) indicating three (3) referees of whom one (1) should be your current or most recent employer not later than 5.00p.m on 25th April 2022 either electronically to the e-mail address hr@nda.or.ug or hand delivered to National Drug Authority office, First Floor, Rumee, Plot 19 Lumumba Avenue opposite TWED PLAZA.
Your application should be addressed to:
The Secretary to the Authority, National Drug Authority
Plot 19, Lumumba Avenue
P.O. Box 23096 Kampala, Uganda
National Drug Authority is an equal Opportunity Employer. Please note that only shortlisted and successful candidate will be contacted.

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