The Pharmacovigilance Scientist serves an integral role in safety data analyses for assigned investigational and/or marketed product(s) in partnership with the Safety Physician. The Pharmacovigilance Scientist is expected to be equally effective working collaboratively and independently. She/he will support activities such as signal management, aggregate reports, RMP development, ad hoc safety query responses, and literature surveillance.
Review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment, including coding, assessment of seriousness, expectedness, and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events. To support the Qualified Person for Pharmacovigilance in the medical understanding and evaluation of any safety issues and to review articles and database outputs.
This role involves information management and pharmacovigilance, requiring receipt, scanning, and documentation of clinical information. The coordinator will work with internal and external clients to request additional information, review patient data, and assist in processing document translations. They will also conduct follow-up activities to ensure the completeness of safety reports.
This position partners with cross functional stakeholders in support of the product safety profile and benefit risk throughout product lifecycle through signal detection, signal evaluation, and preparation of written and verbal summaries of signal management activities and risks to patient safety to present to senior management and regulatory authorities globally.