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.
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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 documentation
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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