Medical Safety Specialist
hace 5 días
About Us
Pfizer is a leading global biopharmaceutical company that applies science and our global resources to bring therapies to people worldwide who are afflicted with serious diseases. Our mission is straightforward: empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
Job Description
We are seeking a highly motivated individual to join our Pharmacovigilance team as a Medical Safety Specialist. As a key member of our team, you will play a vital role in reviewing, preparing, and completing reports of adverse drug experiences, ensuring the safety profile of Pfizer's products meets regulatory requirements.
Key Responsibilities
- Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays
- Assess cases to distinguish those with particular complexities and/or specific issues and escalate appropriately
- Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency
- Generate reports, ensuring adherence to regulatory compliance timelines
- Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation
Requirements
- Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred
- Excellent oral and written communication skills; fluency in spoken and written English; knowledge of additional language(s) an advantage
- Demonstrated computer literacy, particularly in the use and management of relational databases
- Ability to work under supervision in a matrix organization
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