Pharmacovigilance safety expert vs principal scientist

Differences between pharmacovigilance safety expert and principal scientist duties and responsibilities

Pharmacovigilance safety expert example responsibilities.

• Manage compliance issues, and provide feedback for risk assessments within safety/regulatory regulations for FDA reporting.
• Demonstrate and effectively used knowledge of FDA, ICH and GCP and safety reporting guidelines.
• Perform adequate duplicate search in database prior to book-in and creating cases in Argus.
• Develop and maintain training materials using PowerPoint presentations and computer-base training for new and current employees.
• Develop an ELISA biosensor system that detects toxins in food.

Principal scientist example responsibilities.

• Manage pediatric dose development project, technology transfer project and alternate API supplier qualification project on budget and on schedule
• Provide development of and line support for assign immunoassay reagents, calibrators and controls.
• Transfer controls to manufacturing for product launch and include all require studies, testing and documentation under GMP guidelines.
• Maintain several lab documents for ISO certification.
• Understand drug metabolism and pharmacokinetics and design stable molecules.
• Image visualization and manipulation of background plates for animation and post-processing.
Show more