SD Recruitment (Pty) Ltd Posted: 11 November 2020 Cape Town, South Africa Contract Market Related 1 years - 10 years Senior Skills Pharmaceutical Research Management Pharmaceutical Research Job Description SD Recruitment is looking for a Senior/Manager Research Pharmacist for a 6 month contract (possibility of extension) based in Crossroads.The main purpose of this position is to manage the pharmacy according to South African Pharmacy Council (SAPC), Medicines Control Council (MCC), National Institutes of Health (NIH), Good Clinical and Good Pharmacy Practice Guidelines (GCP and GPP).The Pharmacy Manager will be responsible for:Pharmacy Regulatory Compliance includingFamily Planning and Sexually Transmitted Infection medication managementRecord ManagementStaff supervisionKey performance areas (4 - 6) (What)Pharmacy Regulatory and Compliance ManagementActivities / Objectives / Tasks (How)Develop, implement and maintain Pharmacy Standard Operating Procedures and Establishment Plans according to international regulatory standards as specified by multiple research agenciesEnsures the pharmacy is run and managed as according to South African pharmacy and research ethical standards.Manage the Pharmacy as per SAPC Responsible Pharmacist requirementsEnsure annual South African Pharmacy Council (SAPC) accreditation of pharmacyPlan and implement Pharmacy technical appliances - follow up on any issuesResponsible for development and management of equipment maintenance calibration plan.Mentor pharmacists for South African Tuberculosis Vaccine Intervention (SATVI)Backup for Lead Pharmacist of Cape Town Clinical Trials Unit studies (4 pharmacies).Results / Outcomes (Why)Pharmacy is in compliance with all related legislationWrite and revise SOPs on Pharmacy and IP management and response to Equipment failure when requestedAll documentation accurate and up to date at any time checked.Registration as Responsible PharmacistPharmacy meets all SAPC requirementsSAPC inspection reportsAnnual SAPC Pharmacy Registration certificates and Pharmacy staff certificates are up to dateMaintenance logs are up to date.All equipment fully operational and malfunctions are attended to timeouslyReport on Monitoring of logs and service records by study monitors is positiveRecord ManagementActivities / Objectives / Tasks (How)Maintain IP accountability records in accordance with the standards required by the SAPC, MCC, ICH-GCP and IPMMaintain prescription records against which IP is dispensedMaintain Pharmacy sections of the Research Site FilesResults / Outcomes (Why)Records are accurately and timeously captured according to study protocolAll documentation accurate and up to date at any time checked.Family Planning and Sexually Transmitted Infection medication managementActivities / Objectives / Tasks (How)Check prescriptions and advise medical officers as to drug interactions and contra-indications to ensure participant safetyReceive medication from supplier - document receipt and resolve discrepanciesStore medication under correct conditions at the siteDispense medication as per pharmacy regulationsDispose of medication as per pharmacy regulationsResults / Outcomes (Why)Medication is handled according to South African Pharmacy Council (SAPC) and Medicines Control Council (MCC) requirementsDoH monitoring/audit reports are favorable.Investigational Product (IP) ManagementActivities / Objectives / Tasks (How)Responsible for pharmacy related research activities for active protocols, protocols under development and in accreditation.Maintain adequate stock levels of IP at the siteResponsible for randomization (blinding / unbinding) of participants in order to prevent research bias and maintain participant confidentialityReceive IP from supplier - document receipt and resolve discrepanciesStore IP under correct conditions at the siteLabel IP prior to dispensingResponsible for ensuring prescriptions are checked prior to dispensing IP as per randomization protocol.Dispense IP as per specific protocol requirementsReceive and reconcile IP returnsStore IP (used and unused) on site until monitor confirms IP accountabilityDispose of used IP as per sponsor requirementsReturn unused IP to supplier for storage until IP destruction permittedParticipate and assist in funder regulatory and compliance auditsResults / Outcomes (Why)Study product is distributed according to protocolAll trial participants receive IP on time according to protocolOptimal stock levels maintained at all timesTrial monitoring reports regarding Pharmacy always favourableAll documentation accurate and up to date at any time checked.Sponsor monitoring/audit reports are favorableMonitoring reports are favorable and any reports or findings are documentedPharmacy staff supervisionActivities / Objectives / Tasks (How)Line manage the pharmacy staffKeep all pharmacy staff informed of developments within the departmentEnsure all pharmacy staff undergo performance reviews as per UCT HR policyIdentify training needs and organize relevant training initiativesCoach Staff to assist with performance improvementResults / Outcomes (Why)All human resource functions relating to own staff are carried out timeously and in accordance with UCT HR policy, and relevant legislation
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