Malawi Liverpool Wellcome Trust
Job Description
Job Summary
The Malawi-Liverpool-Wellcome Research Programme (MLW) (http://www.mlw.mw) is an internationally recognized centre for research and training, funded by the Wellcome (W) in collaboration with our key partners, the Kamuzu University of Health Sciences (KUHeS), Liverpool School of Tropical Medicine (LSTM) and University of Liverpool (UoL) among others. We are committed to promoting research and training led by Malawian and international scientists, with the aim of conducting science that drives health and well-being in Malawi and elsewhere in the Region.
The program is seeking a capable and forward-thinking individual to join as a Clinical Trials Pre MSc Intern Pharmacist within the Clinical Research Support Unit. This role will report to the Lead Pharmacist.
This Pre MSc-Intern role will contribute to and elevate the visibility of the MLW Programme. It offers valuable research and leadership experience for an ambitious and enthusiastic clinician aiming to forge a career in academic medicine.
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 be 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 or at least having completed the PMRA internship pending registration.
Responsibilities
Pharmacy
- Secure storage of IMPs in accordance with Clinical Trial protocols and in monitored environment. .
- Checking/verifying prescriptions and dispending IMPs accordingly.
- Reconstitution and preparation of IMPs
- 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 requirements.
- 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.
Administrative
- 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
Training
- 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(s).
Requirements
Degree 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.
- Problem solving skill
- Analytical and synthetic thinking skills
- Interest in generating and answering research questions
For more detailed information of the job, please visit the MLW website, www.mlw.mw
Remuneration and Benefits
MLW offers an attractive remuneration package that includes a competitive salary package commensurate with the position, a medical aid scheme,
MLW also offers opportunities such as scholarships, upgrading, and training opportunities to employees. These are based on excellent job performance and other set criteria.
MLW recognizes its responsibility to safeguard and protect communities, research participants, and patients. Please note that successful candidates will be requested to undergo a safeguarding check prior to appointment and at regular time points during employment.
Method Of Application
Suitably qualified candidates should forward their applications with copies of relevant certificates, and a detailed CV as a single PDF to [email protected] and cc [email protected] Please indicate the position title as the heading of your email. Hand-delivered applications will not be processed.
To arrive no later than the 12th September 2023, only short-listed candidates will be acknowledged.
ONLY SHORT-LISTED CANDIDATES WILL BE ACKNOWLEDGED.