Senior Pharmacist, Clinical Trials Unit

Senior Pharmacist, Clinical Trials Unit

Entity: Aga Khan University

Location: Karachi

Introduction:

Aga Khan University, chartered in 1983 as Pakistan’s first private international University, is committed to the provision of education, research, and health care based on international standards relevant to Pakistan and the region. The affiliated Aga Khan University Hospital provides state-of-the-art clinical facilities and well-equipped diagnostic services. The University currently has teaching sites in Pakistan, East Africa, the United Kingdom, and Afghanistan and is a major component of the Aga Khan Development Network.

AKU is an equal opportunity employer and is committed to safeguarding and aims to adopt appropriate standards for ensuring and promoting a respectful relationship with and between all faculty, staff, trainees, volunteers, beneficiaries, wider communities, and other stakeholders with whom it works, including children and vulnerable adults and expects all employees/trainees and partners to share this commitment.

Responsibilities:

The Senior Pharmacist is needed to provide an overall operational oversight to Research Pharmacy operations. The duties and responsibilities include: coordinating, collaborating and providing expertise in support of clinical investigational drug trials; performing education responsibilities; providing accurate and efficient dispensing of medication; performing administrative responsibilities; providing direct and/or functional supervision; maintaining overall responsibility for pharmacy operations in assigned area; performing communication responsibilities; performing other duties consistent with the job classification, as required. The incumbent will be responsible for:

• Maintaining responsibility for clinical investigational drug trials;
• Providing an overall oversight to multiple trials involving Investigational management including but not limited procurement, receiving, storage, dispensing, incineration and documentation management;
• Ensuring that all clinical trials involving investigational medications in CTU are appropriately managed and maintained and that all current legislation, ICH-GCP and policies are followed;
• Liaising with principal investigators and/or study coordinators / CTU Management to establish pharmacy’s role, and to implement dispensing, compounding procedures;
• Communicating with, and trains staff anticipated to participate in any aspect of the clinical investigational drug trial;
• Maintaining a pharmacy binder which contains a study summary, protocol, dispensing procedures, completed samples of required paperwork, dispensing checklist, fee schedule, billing procedures and any other relevant materials for each investigational trial;
• Maintaining an up-to-date investigational drug trials list;
• Maintaining responsibility for the management of the inventory for clinical investigational drug trials; orders, replaces and returns study materials, as required;
• Communicating any concerns regarding ethical issues or deviation from established policies & procedures;
• Actively engaging in investigational medication dispensing, as needed;
• Providing direct supervision; maintains overall responsibility for pharmacy operations;
• Supervising and provides direction to other pharmacy staff;
• Delegating work assignments and checks work performed by other staff;
• Providing input into performance appraisals of support staff;
• Providing technical and procedural guidance;
• Performing administrative responsibilities;
• Attending and contributes to interdisciplinary team meetings relating to clinical investigational drug trials. Monitors pharmacy activities, daily, to ensure adherence to proper inventory record maintenance;
• Completing reports including incident reports, adverse drug reaction reports, etc;
• Performing education responsibilities;
• Providing training to pharmacy, medical, nursing, and other relevant trust staff on clinical trial medicines and processes;
• Performing communication responsibilities;
• Facilitating rapport between the Department of Pharmacy, principal investigators, clinical trial coordinators, research assistants and trial sponsors;
• Effectively communicatingwith colleagues, and allied health professionals;
• Liaising with external agencies/organizations, as required;
• Contributing information about clinical investigational drug trials to the pharmacy newsletter;
• Supervising monitoring visits from CROs and Sponsor;
• Setting-up and update study specific documents. Process amendments in timely manner;
• Establishing and maintain all policies and procedures relating to the pharmacy clinical trials service;

Qualifications:

The incumbent must have:

• Bachelor’s degree in pharmacy/ Pharm-D.
• Professional registration with Pharmacy council of Pakistan
• Master’s degree in pharmacy and/ or additional training in Hospital pharmacy is preferred_Minimum 3-4 years’ experience in hospital pharmacy practice or experience of working in clinical trials preferably pharmacy with progressively increasing responsibilities.
• Knowledge of ICH-GCP and other local and international regulatory guidelines i.e. DRAP, National Bioethics Committee, Institutional Ethics Committee etc.
• Self-motivated, with strong leadership abilities.
• Demonstrates strong analytical, problem-solving skills.
• Strong written and verbal communication skills.Detail oriented, good organizational traits.
• Must be results oriented, multi-tasking, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines.
• Good computer skills; inclination to adopt technology to maximize efficiency.
• Strong Team leading and delegation qualities
• Proven ability to organize and prioritize workload to meet deadlines. Flexible approach to working hours.

Comprehensive reference checks will be conducted.