Research Pharmacist

SD Recruitment is looking for a Senior Research Pharmacist for a 2 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 including
• Family Planning and Sexually Transmitted Infection medication management
• Investigation Product (IP) Management
• Record Management
• Staff supervision

Key performance areas (4 - 6) (What)

• Pharmacy Regulatory and Compliance Management

Activities / Objectives / Tasks (How)

• Develop, implement and maintain Pharmacy Standard Operating Procedures and Establishment Plans according to international regulatory standards as specified by multiple research agencies.
• Ensure the pharmacy is run and managed according to South African pharmacy and research ethical standards.
• Manage the Pharmacy as per SAPC Responsible Pharmacist requirements.
• Ensure annual South African Pharmacy Council (SAPC) accreditation of pharmacy.
• Plan and implement Pharmacy technical appliances - follow up on any issues.
• Responsible 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 legislation.
• Approved Pharmacy Establishment Plan.
• Write and revise SOPs on Pharmacy and IP management and response to Equipment failure when requested.
• All documentation accurate and up to date at any time checked.
• Registration as Responsible Pharmacist.
• Pharmacy meets all SAPC requirements.
• SAPC inspection reports.
• Annual SAPC Pharmacy Registration certificates and Pharmacy staff certificates are up to date.
• Maintenance logs are up to date.
• All equipment fully operational and malfunctions are attended to timeously.
• Report on Monitoring of logs and service records by study monitors is positive.
• Record Management.

Activities / Objectives / Tasks (How)

• Maintain IP accountability records in accordance with the standards required by the SAPC, MCC, ICH-GCP and IPM.
• Maintain prescription records against which IP is dispensed.
• Maintain Pharmacy sections of the Research Site Files.

Results / Outcomes (Why)

• Records are accurately and timeously captured according to study protocol.
• All documentation accurate and up to date at any time checked.
• Family Planning and Sexually Transmitted Infection medication management.

Activities / Objectives / Tasks (How)

• Check prescriptions and advise medical officers as to drug interactions and contra-indications to ensure participant safety.
• Receive medication from supplier - document receipt and resolve discrepancies.
• Store medication under correct conditions at the site.
• Dispense medication as per pharmacy regulations.
• Dispose of medication as per pharmacy regulations.

Results / Outcomes (Why)

• Medication is handled according to South African Pharmacy Council (SAPC) and Medicines Control Council (MCC) requirements.
• DoH monitoring/audit reports are favorable.
• Investigational Product (IP) Management.

Activities / 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 site.
• Responsible for randomization (blinding / unbinding) of participants in order to prevent research bias and maintain participant confidentiality.
• Receive IP from supplier - document receipt and resolve discrepancies.
• Store IP under correct conditions at the site.
• Label IP prior to dispensing.
• Responsible for ensuring prescriptions are checked prior to dispensing IP as per randomization protocol.
• Dispense IP as per specific protocol requirements.
• Receive and reconcile IP returns.
• Store IP (used and unused) on site until monitor confirms IP accountability.
• Dispose of used IP as per sponsor requirements.
• Return unused IP to supplier for storage until IP destruction permitted.
• Participate and assist in funder regulatory and compliance audits.

Results / Outcomes (Why)

• Study product is distributed according to protocol.
• All trial participants receive IP on time according to protocol.
• Optimal stock levels maintained at all times.
• Trial monitoring reports regarding Pharmacy always favorable.
• All documentation accurate and up to date at any time checked.
• Sponsor monitoring/audit reports are favorable.
• Monitoring reports are favorable and any reports or findings are documented.
• Pharmacy staff supervision.

Activities / Objectives / Tasks (How)

• Line manage the pharmacy staff.
• Keep all pharmacy staff informed of developments within the department.
• Ensure all pharmacy staff undergo performance reviews as per UCT HR policy.
• Identify training needs and organize relevant training initiatives.
• Coach Staff to assist with performance improvement.

Results / Outcomes (Why)

• All human resource functions relating to own staff are carried out timeously and in accordance with UCT HR policy, and relevant legislation.

Minimum Requirements

• Pharmacy Degree
• At least 5 years experience