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Posted On: Jul 29, 2024


THE UNITED REPUBLIC OF TANZANIA

MINISTRY OF HEALTH

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY




ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

29th July, 2024

REQUEST FOR EXPRESSION OF INTEREST FOR ASSESSMENT OF MEDICINES SAFETY REPORTS

  1. Tanzania Medicines and Medical Devices Authority (TMDA) is an executive Agency under the Ministry of Health established under the Tanzania Medicines and Medical Devices Act Cap 219. TMDA is responsible for controlling the quality, safety and effectiveness of medicines, medical devices and diagnostics as well as regulation of tobacco products.
  2. The Authority invites expression of interests (EOIs) from qualified Tanzanians to be engaged in the assessment of medicines safety reports for the financial year 2024/2025.
  3. The scope of assignment shall be but not limited to the following technical areas: -
    1. Assessment of Individual Case Safety Reports (ICSR) and commissioning of the same into VIGIBASE;
    2. Assessment of Periodic Safety Updates Reports (PSUR)s;
    3. Assessment of Benefits Risks Evaluation Reports (PBRER)s; and
    4. Assessment of Risk Management Plans (RMP) of medicinal products.
  4. The Assessor must be able to establish benefit-risks balance of medicines and vaccines, appraise the risk mitigation and minimization measures that are to be put in place and give recommendations to the Authority to enable regulatory decision making.
  5. The interested candidates/experts should have the following minimum qualification requirements;
    1. Bachelor degree in Pharmacy, Medicine, Pharmacology, Toxicology, Microbiology or any other health related qualification;
    2. Possession of registration to practice issued by the relevant Professional Body; and
    3. Experience of undertaking similar assignment at least in the last one year.
  6. Additionally, the interested candidates are ought to submit the following: -
    1. A cover letter for the expression of interest addressed to Director General, Tanzania Medicines and Medical Devices Authority, Dodoma – Tanzania;
    2. A detailed CV indicating relevant experience with at least two (2) Referees; and
    3. Certified copies of a degree certificate and registration evidence from relevant Professional Body.
  7. Expression of interest documents should be submitted electronically via the email clinicaltrials@tmda.go.tz and copied to damas.matiko@tmda.go.tz
  8. with subject titled “EXPRESSION OF INTEREST (EOI) FOR ASSESSMENT OF MEDICINES SAFETY REPORTS” addressed to the Director General, Tanzania Medicines and Medical Devices Authority.
  9. For more clarification on this matter, it is advised to visit TMDA Headquarters located at Plot No. 56/1, Block E, Kisasa B Centre, Hombolo Road, P. O. Box 1252, Dodoma – Tanzania from 8.00 am to 3.00 p.m on Monday to Friday except on public holidays or via email: info@tmda.go.tz.
  10. The deadline for submission of EOI is on Saturday 31st August, 2024 at 14:00 hours.
Issued by:
Director General,
Tanzania Medicines and Medical Devices Authority (TMDA),
P.O. Box 1253 Dodoma
Telephone: +255 222 450512/658 445222/777 700002
Email Address: info@tmda.go.tz
Hotline: 0800110084