The Department of Pharmacy within the PRA Business Unit "Early Development Service" is responsible for receiving, storage, preparation, distribution and return of study-related drugs, which covers "Drug Accountability" of clinical trials. The department liaises with clients and ensures an optimal match between client needs and the capabilities of the department. The department advises where needed regarding pharmaceutical aspects and provides preparation protocols (batch records) on demand. The Pharmacy department also manages all non-study-related medication. The processing of Investigational Medicinal Product (IMP) or Active Product Ingredient (API), and in particular reception control and preparations require very high accuracy and knowledge of GMP/ GCP and or FDA regulations.
Ensure that pharmacy facilities are in accordance with GMP, GCP, ICH, FDA, federal, state and local guidelines, whatever regulatory and locally required. Ensure that local requirements are met with respect to licenses e.g. pharmacy license, manufacturer license, import license, DEA license or Permit for handling controlled substances and a license to handle radioactive compounds are maintained. Direct manufacturing, packaging and distribution of the IMP and ensure documentation is optimal and in accordance with above guidelines and in agreement with the sponsor. Responsible for feasibility check of a protocol and/or Investigational Medicinal Product Dossier (IMPD) or Investigational New Drug (IND) with respect to the Investigational Medicinal Product (IMP). Ensure maximum safety/tolerability of IMPs for the volunteer or patient by an optimal composition of the IMP. Represent personnel matters in order to realize a quantitative and qualitative optimal staffing.
Reading and reviewing study protocols
Drafting manufacturing batch records
Checking operations (practical and administrative) of the Pharmacy Assistants.
Distribution of required IMP to the relevant department.
Qualified to be present in every pharmacy area.
Co-Responsible for the pharmaceutical aspects of clinical trials, so manufacturing, packaging and distribution of IMP and documentation is optimal and in accordance with GMP/GCP, ICH, FDA, Federal, State and local guidelines and in agreement with the customer.
Reading and reviewing IMPD or IND's
Consulting sponsors, Project Managers, Physicians and Clinical Study Managers on the manufacturing, distribution and administration of medication.
Responsible as QP for release or reject of the received IMPs or API (from quarantine).
Checking operations of Pharmacists level 1
If radiolabeled studies are conducted acting as radiation officer and responsible for the pharmaceutical aspects (drafting manufacturing batch records and ensure the correct materials) for radiolabeled studies.
Ensure that any remaining and specific samples are recorded, stored, and, if necessary shipped under the correct conditions.
Ensure that non-study-related medications (crash carts and supplies general medication) are periodically inspected, with respect to completeness and expired medication. If needed medication will be added or replaced.
Guarantee the route of the IMP, during the study (according to GMP), is traceable.
Drafting (Standard Operating) Procedures and forms for specific tasks within the department, taking into account the GMP/GCP, ICH, FDA, Federal, State and local guidelines.
Responsible as a site pharmacist or QP for release or reject of the received IMPs or API (from quarantine).
Responsible as QP for QC checks and final of IMP's manufactured such that the safety of the volunteer (with respect to the IMP) is guaranteed.
The start of a recall when safety cannot be guaranteed, with respect to IMP.
Responsible for environmental monitoring of the pharmacy facilities so all manufacturing facilities are in compliance with GMP.
Responsibilities as a Qualified Person (QP) as specified in relevant sections (Annex 16) GMP and GCP and the authority as a Radiation Officer.
Read, write, and speak fluent English; fluent in host country language required
Demonstrate dedication to quality and reliability in all work tasks
Practical experience of at least 2 years as a pharmacist level 2 or similar function in the industry
Additional courses related to GMP/QP
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PRA Health Sciences