Senior/Manager Research Pharmacist - 6 Month Contract
Location Cape Town, South Africa Employment Type Contract Seniority Level Senior Experience 1 to 10 years Remuneration Remuneration Type Market Related Remuneration Frequency Monthly Benefits -
Skills
Pharmaceutical
Research
Management
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 including
Family Planning and Sexually Transmitted Infection medication 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
Ensures the pharmacy is run and managed as 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
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 favourable
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
