ROLE SUMMARY
Reporting to the Head of Global Clinical Supply Manila Operations (GMO) / GMO Team Lead, with dotted line reporting to the Executive Director of Clinical Research Pharmacy. The clinical Operations Pharmacist (COP) role will provide support and local pharmacy practice expertise
in the development and management of investigational products at a program and protocol level specifically in the development of Investigational Product Handling documents and tools (i.e. investigational product handling manuals, administration instructions, and dispensing guidelines, patient dosing instructions for utilization by clinical sites).
The COP will provide support to the Clinical Research Pharmacist - Therapeutic Area Pharmacists in the development and provision of supplemental investigational product handling information.
Assist in the education of 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. When necessary, provide support in responding to queries from clinical project teams
regarding medication/device related issues, such as concomitant medications, exclusionary medications and patient compliance/adherence issues.
Support the development of protocol Investigational Product Manuals (IPM) and IP supporting documentation (e.g. Dose Preparation Records)
Attend team meetings and provide patient focus support in the design of IP clinical labeling and packaging
Act as secondary Point of Contact for clinical site queries on IP administration, formulation preparation, labelling and/or packaging
Assist in development and provision of IP training at investigator meetings (IM) and site initiation visits (SIV)
Support the CRP leadership on GCS strategic and process improvement initiatives
Support the review and trending of Site 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
Maintain good working relationships with external partners
Basic Qualifications
A degree in Pharmacy with at least 2 years of hospital pharmacy or equivalent pharmaceutical/biotech industry experience.
Fluent in written and spoken English
Preferred Qualifications
Completion of a post-PharmD Industry Fellowship or pharmacy practice residency is desirable.
Hospital pharmacy or clinical research experience (i.e. CRA/Monitoring) preferred.
Fluent in written and spoken Mandarin
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Attend periodic meetings with teams in other global time zones outside normal work hours.
Work Location Assignment: Hybrid
#LI-PFE
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Research and Development
#LI-PFE
Pfizer
Reporting to the Head of Global Clinical Supply Manila Operations (GMO) / GMO Team Lead, with dotted line reporting to the Executive Director of Clinical Research Pharmacy. The clinical Operations Pharmacist (COP) role will provide support and local pharmacy practice expertise
in the development and management of investigational products at a program and protocol level specifically in the development of Investigational Product Handling documents and tools (i.e. investigational product handling manuals, administration instructions, and dispensing guidelines, patient dosing instructions for utilization by clinical sites).
The COP will provide support to the Clinical Research Pharmacist - Therapeutic Area Pharmacists in the development and provision of supplemental investigational product handling information.
Assist in the education of 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. When necessary, provide support in responding to queries from clinical project teams
regarding medication/device related issues, such as concomitant medications, exclusionary medications and patient compliance/adherence issues.
Support the development of protocol Investigational Product Manuals (IPM) and IP supporting documentation (e.g. Dose Preparation Records)
Attend team meetings and provide patient focus support in the design of IP clinical labeling and packaging
Act as secondary Point of Contact for clinical site queries on IP administration, formulation preparation, labelling and/or packaging
Assist in development and provision of IP training at investigator meetings (IM) and site initiation visits (SIV)
Support the CRP leadership on GCS strategic and process improvement initiatives
Support the review and trending of Site 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
Maintain good working relationships with external partners
Basic Qualifications
A degree in Pharmacy with at least 2 years of hospital pharmacy or equivalent pharmaceutical/biotech industry experience.
Fluent in written and spoken English
Preferred Qualifications
Completion of a post-PharmD Industry Fellowship or pharmacy practice residency is desirable.
Hospital pharmacy or clinical research experience (i.e. CRA/Monitoring) preferred.
Fluent in written and spoken Mandarin
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Attend periodic meetings with teams in other global time zones outside normal work hours.
Work Location Assignment: Hybrid
#LI-PFE
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Research and Development
#LI-PFE
Pfizer
Other Info
Makati City, Metro Manila
Permanent
Full-time
Permanent
Full-time
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Pfizer
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Customer Success Operations Associate (B2B SaaS) - Work From Home
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