Senior PV Operations Manager - Safety & Compliance

amylyx

Cambridge (MA)

On-site

USD 140,000 - 190,000

Full time

6 days ago
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Job summary

Amylyx is seeking a Senior Manager, Pharmacovigilance Operations to lead day-to-day pharmacovigilance operations across safety databases, case processing, and safety reporting for investigational and marketed products.

This role requires hands-on oversight of ICSR processing, safety reporting, vendor activities, data reconciliation, and aggregate reporting, ensuring high-quality, compliant, and timely execution of global PV activities.

Job description

Amylyx is seeking a Senior Manager, Pharmacovigilance Operations to lead day-to-day pharmacovigilance operations across safety databases, case processing, and safety reporting for investigational and marketed products.

This role requires hands-on oversight of ICSR processing, safety reporting, vendor activities, data reconciliation, and aggregate reporting, ensuring high-quality, compliant, and timely execution of global PV activities.

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