Description of services to be provided:
Under the supervision of the Activity Lead and Technical Manager, the consultant will support the MTaPS team to conduct a training on risk-benefit assessment and evaluation, post authorization safety studies, and conducting active surveillance.The consultant will undertake the following activities:

1. Develop training design, contents, and materials (e.g., program, slide deck, preand
post-test, cases or exercises, course evaluation) relevant to:
a) Conducting an active surveillance.
b) Conducting Post Authorisation Safety Studies (PASS)
c) Review and evaluation of Periodic safety update report (PSUR)/Periodic
benefit-risk evaluation report (PBRER).
2. Deliver the three to five (3-5) -days training to the ASEAN member states.
3. Prepare the training report.

QUALIFICATIONS

1. Master's degree in health-related field with specialized training and/or experience in pharmacovigilance, clinical pharmacology and pharmacoepidemiology.
2. Minimum 7 years relevant work experience in pharmacovigilance and regulatory setting.
3. In-depth background and knowledge on the theory and practice of Pharmacovigilance including international principles, policies, and regulations on pharmacovigilance.
4. Extensive knowledge and skills on the conduct and implementation of active surveillance and post authorisation safety studies, risk-benefit assessment methods, risk minimization and management plans and their application in pharmacovigilance decision making.
5. Prior experience and knowledge in evaluating periodic benefit- risk evaluation reports/periodic safety update reports, pharmacovigilance decision making.
6. Prior experience working with USAID-funded projects preferred.
7. Previous work as national medicines regulatory authority officer and/or national pharmacovigilance centre officer preferred.
8. Experience providing technical assistance and knowledge of WHO led system for regulatory system strengthening to regulatory authorities in LMICs.
9. Demonstrated skills in stakeholder engagement and management, especially with government representatives.
10. Possess well-established interpersonal, decision-making, and organizational skills, along with practiced training skills.
11. Ability to prepare a training materials and presentations.
12. Proven experience and ability on provision of training
13. Excellent written and verbal communication skills in English is required.
14. Ability to undertake work with minimum supervision.
15. Ability to conduct the activities within the allocated time.

MSH is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, sex, sexual orientation, gender or gender identity, religion, creed, citizenship, national origin, age, veteran status, or disability unrelated to job requirements. MSH will take affirmative action to ensure that qualified applicants are employed and that employees are treated without regard to their race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran and disability status. In compliance with U.S. Department of Labor Executive Order 11246, Section 503 of the Rehabilitation Act, and Section 4212 of the Vietnam Era Readjustment Assistance Act, MSH has developed and maintains an affirmative action program and plan.

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