Senior Manager, Pharmacovigilance Operations

📋 Description

• Support the day-to-day execution of pharmacovigilance operations for investigational and marketed
• Provide hands-on oversight of Individual Case Safety Report (ICSR) processing activities performed
• Monitor case processing workflows to ensure accurate and timely intake, processing, follow-up
• Track compliance with expedited reporting requirements and escalate potential compliance issues to
• Coordinate and oversee safety information received from multiple sources, including clinical
• Partner with external pharmacovigilance vendors on day-to-day operational activities, issue

🎯 Requirements

• Degreed in a scientific, healthcare, nursing, pharmacy, or related discipline required and
• Proficient with ICSR processing, expedited safety reporting, clinical trial safety activities
• Experience providing operational oversight of internal client facing team or external
• Proficient in U.S. and global pharmacovigilance regulations and guidance, including FDA, EMA, ICH
• Proficient with pharmacovigilance databases and safety systems; experience with Veeva Safety or
• Experience supporting clinical-stage development programs required; experience with marketed

🎁 Benefits

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and
• You must have access to work in a setting which enables meeting the requirements of the role