Role Description
The role of the Pfizer Records Service Centre (PRSC) GLP Archivist will be to
assure that all archived preclinical records (physical and electronic) are
retained in accordance with GLP regulations, and organized in a manner that
ensures rapid retrieval if required to support business activities or in the event
of an internal or external audit/inspection. The scope of this role includes
producing the information assets (electronic files, paper, tissue samples,
slides, and blocks) upon demand, as well as hosting any on-site inspection of
the records during an audit. This role provides leadership and strategic
direction for records lifecycle management and chain of custody within the
area of preclinical research and development.
Responsibilities
• Supports internal and external PRSC inspections and audits interfacing with
company and agency professionals as appropriate
• Maintains and improves information management for the historical collection
of GLP records, including application of retention and record destruction
• Ensure that SOPs related to archiving of GLP records are seamless across
the different lines (DSRD, EU PRSC, PGM / GO)
• Leads cross-functional projects setting priority and managing budgets to
deliver technical and operational solutions to implement process improvements
both within the PRSC and in the business line
• Support customer requests for records in a timely and cost effective manner
• Serves as primary point of contact for management of preclinical records
from European and Asian Contract Research Organizations
• Supports definition of global metadata standards for physical and electronic
media to assure compliance with corporate retention schedule and external
industry/health authority requirements
• Carry out complex searches across various Pfizer systems to ensure retrieval
of complete and accurate information as appropriate for customer requests
and/or audits
• Drive alignment and standardization for processes related to
record/information collection or retrieval projects
• Provide consultancy for records management processes as applied to
business records generated during the drug development process
• Provides leadership and prioritization for the effective execution and delivery
of strategic imperatives related to information management systems
• Maintain a professional awareness of developments in information
management through appropriate reading, networking and attendance at
conferences and training courses
• Assess customer service metrics to improve processes and customer support
• Keep abreast with developments in the GLP compliance area and good
records management practices
Qualifications
BA or BS in a relevant science
Compliance experience in the pharmaceutical industry (preferably GLP)
Significant knowledge of records management practices in a regulated
environment
Knowledge of the non clinical drug development process and supporting
information
Computer literacy and competence with standard office tools
Demonstrate ability to manage several projects and/or complex/global projects
Proven written and oral communication and presentation skills
Demonstrated ability to maintain confidentiality
Ability to work in a globally matrixed team to identify and implement best
practices
An independent thinker who can represent global teams to their colleagues at
their site, and represent their colleagues to the site to the global team
Excellent customer focus oriented and proven listening skills
To apply please go to www.pfizer.com/careers and reference 932337 as the
Job opening ID. If you have any difficulties applying, please email
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For any technical queries re JISC please email [log in to unmask]
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