Medical Data Analyst
2 tygodni temu
Pfizer is committed to transforming lives through innovation and discovery. As a key member of our Worldwide Safety department, you will play a vital role in ensuring the safety and efficacy of our products.
We are seeking a highly motivated and detail-oriented individual to join our team as a Drug Safety Surveillance/Pharmacovigilance Associate. In this role, you will be responsible for reviewing, preparing, and completing individual case safety reports of adverse drug experiences originating from any source in the global safety database.
You will work closely with our Case Processing Team Lead to ensure adherence to regulatory requirements and maintain the accuracy and consistency of data presented in assigned cases.
- Main Responsibilities:
- Identifying, assessing, and processing cases, including writing and editing of case narrative, to allow the generation of reports and ensure adherence to regulatory compliance timelines.
- Selecting routine cases for processing, determining the appropriate prioritization criteria, and noting reasons for any delays.
- Reviewing, ranking, processing, and documenting event terms, case classifications (validity, seriousness, labeling), special scenarios, product complaint information, reportability with due date, accuracy, and consistency.
- Assessing cases to distinguish those with complexities and/or specific issues requiring proper escalation.
- Determination of appropriate case follow-up, requesting follow-up letters when appropriate.
- Applying corporate and global regulations, guidelines, Standard Operating Procedures, and writing practices, data entry conventions, and search functions in the safety database.
- Bachelor's degree in a science-related field or equivalent (healthcare professional qualification preferred).
- Experience in pharmacovigilance, regulatory, or clinical or scientific research is an advantage but not a requirement.
- Fluent English comprehension, reading, and speaking skills (B2 or higher) and German or French (B2 or higher) is a requirement.
- Ability to manage data in a Safety database (Argus preferred) is an advantage but not a requirement.
- Microsoft Office competent user (mainly Word, PowerPoint, Excel).
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