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Why Patients Need You

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting
evidenced based, medical decision support with colleagues and stakeholders to
enable better health and treatment outcomes. Whether you are creating framework
necessary to ensure our evidence is scientifically sound, providing unbiased,
medically necessary expertise or investigating how to close gaps in data, our
mission is simple. Empower healthcare decisions regarding the safe and
appropriate use of medicines for patients.



What You Will Achieve

It is our mission to strengthen the oversight of our clinical data through
stronger ownership, control, and visibility. You will play an important role in
processing, reviewing and receiving clinical data and records and from
therapeutic groups as well as internal and outside investigators. You will
ensure that accurate, timely, and consistent data reaches the clinical teams
and other groups. You will be relied on for data management plans including
data preparation and validation activities, among others.



As an associate, your focus on the job will contribute in achieving project
tasks and goals. Through your domain knowledge and commitment, you will create
a collaborative team environment for your colleagues.



It is your commitment and hard work that will help make Pfizer ready to
achieve new milestones and help patients across the globe.



How You Will Achieve It

* Process TMF documents received per good documentation practices, TMF
readiness critieria and other reference documents
* Demonstrate understanding of document types, properties and indexing
requirements
* Ensure overall TMF quality in terms of document completeness, indexing and
scanning accuracy
* Process documents in the TMF system(s) within specified timelines, based on
document criticality/priority
* Communicate document inquiries with responsible users as needed
* Liaise with Document Owners, TMF Study Owners and/or other end users to
resolve document related discrepancies and issues
* Communicate and escalate issues to the TMF Document Specialist Lead and TMF
Operations when needed
* Contribute to process improvement initiatives and projects that may arise
* Can be identified as Subject Matter Expert for TMF process, systems and
related tools, where applicable


Qualifications

Must-Have

* Bachelor's Degree
* Demonstrated experience or knowledge of ICH/GCP (International Council for
Harmonization/ Good Clinical Practice) documentation requirements
* Hands-on experience with electronic documentation management systems and/or
web based data management systems
* Awareness of clinical development process including knowledge and
understanding of the principles of Good Clinical Practice
* Understanding of regulatory requirements and relevant data standards
* Consistent, detail-oriented, and dedicated to excellence
* Strong oral and written English communications skills
* Proficiency in the use of Microsoft Office Suite of tools


Nice-to-Have

* Experience in management of medical and clinical study records and
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Pfizer is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.




Medical



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