Global Clinical Supply Clinical Research Pharmacist

The Global Clinical Supply (GCS) Clinical Research Pharmacist (CRP) is a position within the GCS Strategic Hubs (GSH) and will be based in Costa Rica.  The GCS CRP will be reporting to the GCS Global Clinical Supply Strategic Hubs (GSH) Team Lead based in Costa Rica, with a matrix reporting relationship to the Director of Clinical Research Pharmacy or higher.

The Clinical Research Pharmacy delivers Pfizer Clinical Study Pharmaceutical Care which are the instructions and training that make the breakthroughs possible by partnering with clinical sites, helping them to provide the very best care to their patients enrolled in Pfizer clinical trials.  By focusing on the needs of the patient throughout the development process by designing packaging, labels, and dosing tools that facilitate optimum use of the investigational products being studied The CRP delivers an exceptional clinical trial experience. 

This role will provide clinical research pharmacy expertise in the development and management of investigational products at a program and protocol level (i.e. investigational product handling manuals/pharmacy manuals for utilization by clinical sites)

The Clinical Research Pharmacists will:

• Provide expertise across GCS on clinical site/pharmacy operations; aseptic preparation guidelines for injectables; clinical disease state and patient journey reviews.

• Provide support to GCS functional lines, Pfizer Research and Development (PRD) and Oncology Research & Development (ORD) on the creation of Investigational Product (IP) handling documents.

• Educate clinical site personnel through in-services, investigator meetings and clinical site initiations or follow-up visits on the proper handling and use of investigational products.

• Provide consultation to clinical project teams on medication/device related issues, such as concomitant medications, exclusionary medications and patient compliance/adherence issues.

Role Responsibilities:

• Responsible for the provision of clinical pharmacy expertise to GCS functional teams (e.g. CSSM, CSIT, GCSO – clinical disease state and patient journey reviews) and Pfizer colleagues (e.g.  PRD and ORD - clinical site pharmacy operations; aseptic preparation guidelines for injectables).

• Independently drive and own development and provision of urgent IP handling materials.

• Assess the risks associated with IP Handling as described in the protocol and develop a CRP Risk Assessment and Mitigation Strategy for study protocol with guidance.

• Provide patient focus support to the Clinical Supply Team (CST) in the design of clinical labeling and packaging for use in clinical studies.

• Support the provision of clinical pharmacy expertise to GCS functional teams and Pfizer colleagues.

• Support the development of clinical study protocols and Dosage Administration Instructions (DAI), specifically providing clinical pharmacy guidance with the handling, preparation and administration of investigational products at clinical sites.

• Provide clinical pharmacy expertise in the development and management of investigational product handling manuals/pharmacy manuals for utilization by clinical sites.

• Educate clinical site personnel through in-services, investigator meetings and clinical site initiations or follow-up visits on the proper handling and use of investigational products.

• Provide consultation to clinical project teams on medication/device related issues, such as concomitant medications, exclusionary medications and patient compliance/adherence issues.

• Support the review and trending of Significant Quality Events (SQE) to identify potential risk indicators and mitigations.

• Support GCS matrix stakeholders & networks to promote greater understanding of IP handling challenges and solutions at clinical sites.

• Liaise with key partner and customer contacts (PRD and ORD) to gather clinical development plans, and review supply strategies in conjunction with the Supply Chain Leads (SCL).

• Interface with PRD and ORD Strategic Partners to lead Investigational Product (IP) handling strategy and execution associated with study management activities.

• Foster strong working relationships with internal (GCS functional lines) and external (i.e., Clinical Development & Operations (CD&O)) partners at Pfizer.

• Act as secondary Point of Contact for site personnel engaged in IP handling activities as an investigator site.

  • Review reports and provides site specific trackers/dashboards oversight to support IP handling activities.

  •  Coordinate the IP for predictive patient enrollment to ensure