The post holder will store, account and dispense Investigational Medicinal Products(IMPs) and other concomitant medications in accordance to Clinical Trial protocols and Local MLW pharmacy MLW SOPs. He/She will reconciling key regulatory documents and pharmacy files for the Clinical Trials and ensure a coordinated implementation and closure of Clinical Trial protocols according to study specific and/or MLW Generic Pharmacy SOPs.. He/she will be responsible for conducting audits and ensuring quality, in compliance with and collaborating with funders and LSTM. He/She will be familiar with Malawian Legislation pertaining to management of Clinical research investigational medicinal products. The post holder will be registered with the PMRA.
- Secure storage of IMPs in accordance with Clinical Trial protocols and in monitored environment.
- Checking/verifying prescriptions and dispending IMPs accordingly.
- Giving advice on correct use of medicinal products including dosage and risks.
- Maintain accurate accountability records
- Reconciliation of IMPs in MLW pharmacy stock and returned by participants/Clinical Trial representatives
- Allow pharmacy quality assurance and control activities by CRSU, Sponsor monitors and auditors, Regulatory authority and ethics committees during monitoring, audits or inspections.
- Code breaking in emergency situations.
- Training of study team(s) and MLW staff in pharmaceutical aspects of trial.
- Recording temperature of IMP storage facilities, reviewing and maintaining electronic temperature records.
- Maintaining vaccines and other temperature sensitive products under cold chain conditions, including conditioning of cool boxes.
- Ensuring regular servicing of Temperature regulating devices and performance verification of temperature monitoring devices.
- Ordering and controlling stock and other pharmacy supplies.
- Coordinate the destruction of returned and unused expired IMPs.
- Assistance in resolving data queries.
- Archiving of trial information in accordance with legal required.
- Maintaining a safe and clean pharmacy in accordance with MLW Generic pharmacy SOP.
- Maintain proper storage and security for IMPs.
- Conducting monthly inventory for IMPs and concomitant medications.
- Attending team meetings
- Completing reports including incident reports where necessary
- Attending teleconferences
- Disseminating new information related to the pharmacy unit to researchers and senior managers
- Providing training on IMP and concomitant medication handling to research staff.
- Maintaining professional development.
- Attending Good Clinical Practice (GCP) and Human Subject Protection training and refresher courses.
- Attend Clinical Trial specific protocol trainings.
HEALTH & SAFETY
To take full responsibility for ensuring a safe work environment for the pharmacy by following health and safety rules at all times for colleagues, study participants and oneself and maintaining awareness of Health and Safety issues, for example by attending scheduled refresher meeting.
All staff are employed under the MLW Programme and are ultimately responsible to the Programme whether directly employed under the core grant, a research fellowship or project grant. All staff are expected to be flexible and may be required to contribute to the activities of the Core Programme or another project
Diploma in pharmacy, PMRA practising licence
Other key skills and competences
- Dispensing kills
- Drug reconstitution skills
- Proven experience in dealing with local drug regulatory authorities and oversight of pharmacy in Clinical Trials in accordance with Local Standard Operating Procedures(SOPs).
- Excellent writing and computer operating skills (including MS Word, Access, Publisher and Excel)
- Excellent interpersonal skills
- Should be a fast learner
- GCP certificate will be an added advantage.
To apply for this job please visit www.mlw.mw .