Background information about the job or company (e.g., role context, company overview)

Medical Jobs. KEMRI Jobs

Responsibilities or duties

Key Responsibilities:

• Assume professional responsibility for all pharmacy services for the trial.
• Participate in protocol development, submission, and manuscript writing/review
• Maintain a thorough understanding of the study protocol, study specific procedures, randomization procedures, trial logistics, and pharmacy requirements to support effective trial conduct.
• Contribute to the development of standard operating procedures (SOPs) and quality systems.
• Support participant randomization process in line with the protocol, ensuring correct linkage between randomization codes and dispensing of the IMP.
• Train and supervise pharmaceutical technologists, dispensers, and all research staff involved in Investigational Product (IP) handling
• Manage regulatory applications for import/export permits, drug testing at the NQCL, and authorization for pharmaceutical destruction.
• Develop product specifications and support IMP management, including ordering, receipt, documentation, secure storage, access control, inventory management, and reconciliation.
• Dispense the investigational medicinal product and prescribed participant drugs for acute illness and maintain accurate records of all dispensed drugs to ensure accountability and traceability.
• Maintain complete, accurate, and audit-ready pharmacy records, including dispensing logs, inventory records, accountability logs, temperature logs, and study documentation.
• Conduct quality checks on investigational product, report discrepancies, deviations, and temperature excursions, and coordinate return or destruction of unused or expired IMPs at study close-out.
• Participate in site monitoring visits, audits, and inspections
• Ensure IMP storage equipment is validated and in good working condition
• Support participant safety by contributing to pharmacovigilance activities, including monitoring, documentation, and timely reporting of adverse events, SAEs, SUSARs, and protocol deviations.
• Maintain a compliant, organized, and secure pharmacy environment

General Responsibilities:

Provide routine clinical services and perform any other research, administrative, or delegated duties as assigned by the Principal Investigators.

Qualifications or requirements (e.g., education, skills)

Qualifications

• Bachelor’s Degree in pharmacy or any other relevant field from a recognized university Mandatory
• Must be registered with the Pharmacy & Poisons Board. Mandatory
• Registration Certificate as a Pharmacist (PPB), Annual Practice License for a Pharmacist (PPB) Mandatory
• Sound knowledge of GCP, SOPs, Pharmacy law and regulatory requirements, and pharmacovigilance. Mandatory

Experience needed

• Experience working in vaccine or maternal–infant studies is an added advantage Added Advantage

Any other provided details (e.g., benefits, work environment, team info, or additional notes)

• Demonstrated high levels of integrity and confidentiality Ethics & Integrity
• Excellent interpersonal, verbal and written communication skills Skills & Competencies
• Ability to work with diverse, multidisciplinary teams and build strong relationships with internal and external collaborators Skills & Competencies
• Excellent analytical skills and ability to deliver quality outputs within strict timelines. Skills & Competencies
• Strong team management and decision-making skills Skills & Competencies

• Assume professional responsibility for all pharmacy services for the trial.
• Participate in protocol development, submission, and manuscript writing/review
• Maintain a thorough understanding of the study protocol, study specific procedures, randomization procedures, trial logistics, and pharmacy requirements to support effective trial conduct.
• Contribute to the development of standard operating procedures (SOPs) and quality systems.
• Support participant randomization process in line with the protocol, ensuring correct linkage between randomization codes and dispensing of the IMP.
• Train and supervise pharmaceutical technologists, dispensers, and all research staff involved in Investigational Product (IP) handling
• Manage regulatory applications for import/export permits, drug testing at the NQCL, and authorization for pharmaceutical destruction.
• Develop product specifications and support IMP management, including ordering, receipt, documentation, secure storage, access control, inventory management, and reconciliation.
• Dispense the investigational medicinal product and prescribed participant drugs for acute illness and maintain accurate records of all dispensed drugs to ensure accountability and traceability.
• Maintain complete, accurate, and audit-ready pharmacy records, including dispensing logs, inventory records, accountability logs, temperature logs, and study documentation.
• Conduct quality checks on investigational product, report discrepancies, deviations, and temperature excursions, and coordinate return or destruction of unused or expired IMPs at study close-out.
• Participate in site monitoring visits, audits, and inspections
• Ensure IMP storage equipment is validated and in good working condition
• Support participant safety by contributing to pharmacovigilance activities, including monitoring, documentation, and timely reporting of adverse events, SAEs, SUSARs, and protocol deviations.
• Maintain a compliant, organized, and secure pharmacy environment
• Provide routine clinical services and perform any other research, administrative, or delegated duties as assigned by the Principal Investigators.

• Excellent interpersonal, verbal and written communication skills
• Ability to work with diverse, multidisciplinary teams and build strong relationships with internal and external collaborators
• Excellent analytical skills and ability to deliver quality outputs within strict timelines.
• Strong team management and decision-making skills

• Bachelor’s Degree in pharmacy or any other relevant field from a recognized university Mandatory
• Must be registered with the Pharmacy & Poisons Board. Mandatory
• Registration Certificate as a Pharmacist (PPB), Annual Practice License for a Pharmacist (PPB) Mandatory
• Sound knowledge of GCP, SOPs, Pharmacy law and regulatory requirements, and pharmacovigilance. Mandatory
• Experience working in vaccine or maternal–infant studies is an added advantage Added Advantage
• Demonstrated high levels of integrity and confidentiality