Remote-Eligible Senior Pharmacovigilance Operations Manager

Amylyx Pharmaceuticals; Cambridge (MA); Hybrid; USD 159,000 - 179,000; Full time

Job summary

Amylyx Pharmaceuticals in Cambridge, MA is seeking a Senior Manager, Pharmacovigilance Operations to lead and optimize day-to-day pharmacovigilance activities across clinical and marketed programs.

You will oversee ICSR processing, safety reporting, vendor governance, and data reconciliation while ensuring regulatory compliance and quality. This role requires strong cross‑functional collaboration and attention to detail in a fast-paced biotech setting.

Qualifications

• Bachelor's degree in a scientific, healthcare, nursing, pharmacy, or related discipline.
• 7+ years of relevant pharmaceutical, biotechnology, CRO, or pharmacovigilance experience preferred.
• Experience with ICSR processing, expedited safety reporting, and aggregate reporting.

Responsibilities

• Oversee day-to-day pharmacovigilance operations for investigational and marketed products.
• Provide hands-on oversight of ICSR processing and vendor activities.
• Ensure timely, compliant safety reporting and data reconciliation across programs.
• Coordinate safety data collection from trials, literature, and other sources.
• Maintain safety documentation, SOPs, and compliance dashboards.

Skills

ICSR processing

Regulatory compliance

Vendor management

Pharmacovigilance operations

Written and verbal communication

Education

Bachelor's degree in a scientific field

Tools

Veeva Safety

Job description

Amylyx Pharmaceuticals in Cambridge, MA is seeking a Senior Manager, Pharmacovigilance Operations to lead and optimize day-to-day pharmacovigilance activities across clinical and marketed programs.

You will oversee ICSR processing, safety reporting, vendor governance, and data reconciliation while ensuring regulatory compliance and quality. This role requires strong cross‑functional collaboration and attention to detail in a fast-paced biotech setting.