Pharmacist - Kilifi

Key Responsibilities

• Trial Pharmacy Management: Assume professional responsibility for all pharmacy services for the trial. Maintain a thorough understanding of the study protocol, study-specific procedures, randomization procedures, trial logistics, and pharmacy requirements.
• Standard Operating Procedures: Contribute to the development of standard operating procedures (SOPs) and quality systems.
• Randomization Support: Support participant randomization process in line with the protocol, ensuring correct linkage between randomization codes and dispensing of the Investigational Medicinal Product (IMP).
• Training & Supervision: Train and supervise pharmaceutical technologists, dispensers, and all research staff involved in Investigational Product (IP) handling.
• Regulatory Compliance: Manage regulatory applications for import/export permits, drug testing at the NQCL, and authorization for pharmaceutical destruction.
• Inventory & IMP Management: Develop product specifications and support IMP management, including ordering, receipt, documentation, secure storage, access control, inventory management, and reconciliation.
• Dispensing & Records: 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.
• Quality Control & Audits: Conduct quality checks on investigational products, report discrepancies, deviations, and temperature excursions, and coordinate return or destruction of unused or expired IMPs. Participate in site monitoring visits, audits, and inspections.
• Safety & Pharmacovigilance: Support participant safety by contributing to pharmacovigilance activities, including monitoring, documentation, and timely reporting of adverse events, SAEs, SUSARs, and protocol deviations.
• General Duties: Provide routine clinical services and perform any other research, administrative, or delegated duties as assigned by the Principal Investigators.

Vacancy Requirements

• Education: Bachelor’s Degree in pharmacy or any other relevant field from a recognized university (Mandatory).
• Registration: Registered with the Pharmacy & Poisons Board (Mandatory).
• Licensing: Registration Certificate as a Pharmacist (PPB), Annual Practice License for a Pharmacist (PPB) (Mandatory).
• Technical Knowledge: Sound knowledge of GCP, SOPs, Pharmacy law, regulatory requirements, and pharmacovigilance (Mandatory).
• Experience: Experience working in vaccine or maternal–infant studies is an added advantage.
• Soft Skills: High levels of integrity and confidentiality, excellent communication, teamwork, analytical capability, and decision-making skills.