Participates in activities related to, and processing of Adverse Events for BioMarin post marketed products and investigational products.
• Accountable for accurate data capture for individual case safety reports
• Responsible for narrative creation for individual case safety reports
• Perform quality review (as appropriate)
• Ensuring departmental workflow processes and timelines are followed
• Proactively managing workload to ensure regulatory timelines are met
• Demonstrated knowledge of safety concepts, global regulatory reporting obligations
Bachelor’s degree in Life Science preferred.
• Minimum of 1 year previous Pharmacovigilance experience required.
• Strong knowledge of medical terminology.
• Strong organizational skills, detail oriented, ability to adapt to change
• Proven team player with the ability to function in a multi-disciplinary environment
• Demonstrates initiative and accountability
• Excellent communication skills, both verbal and written
• Computer literate