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.
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