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.
Vacancy Requirements:
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 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