Senior Manager, Pharmacovigilance Operations

amylyx; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

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 has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine's toughest problems.

The Opportunity

The Senior Manager, Pharmacovigilance Operations will be a key member of the Patient Safety and Pharmacovigilance team responsible for the day-to-day execution, oversight, and continuous improvement of pharmacovigilance operational activities supporting Amylyx's clinical development programs and marketed products.

Reporting to the Director, Pharmacovigilance Operations, this role will provide hands-on operational oversight of the Pharmacovigilance safety database, safety case processing, safety reporting, vendor activities, safety data reconciliation, aggregate reporting activities, and other core pharmacovigilance processes. The Senior Manager will partner closely with internal stakeholders and external vendors to ensure high-quality, compliant, and timely execution of global pharmacovigilance activities.

This is a highly collaborative and operational role requiring strong attention to detail, sound judgment, and the ability to manage multiple priorities in a fast-paced and evolving biotechnology environment.

Responsibilities

• Support the day-to-day execution of pharmacovigilance operations for investigational and marketed products in compliance with Amylyx procedures and applicable global regulatory requirements.
• Provide hands-on oversight of Individual Case Safety Report (ICSR) processing activities performed internally and/or by external pharmacovigilance vendors.
• Monitor case processing workflows to ensure accurate and timely intake, processing, follow-up, quality review, and timely submission of safety reports.
• Track compliance with expedited reporting requirements and
• Coordinate and oversee safety information received from multiple sources, including clinical trials, spontaneous reports, literature, medical information, patient support programs, market research programs, call centers, and other applicable sources.
• Partner with external pharmacovigilance vendors on day-to-day operational activities, issue resolution, workload management, and deliverables.
• Monitor vendor performance against established service-level agreements, key performance indicators, quality measures, and timelines; identify and
• Support vendor onboarding, training, governance meetings, documentation, and ongoing operational oversight.
• Coordinate the development, implementation, and maintenance of Safety Data Exchange Agreements, Safety Management Plans, and other pharmacovigilance agreements and operational plans.
• Partner with Clinical Operations, Data Management, CROs, and other stakeholders to coordinate safety data collection and reconciliation activities for clinical trials.
• Plan and execute safety database reconciliations and support timely resolution of discrepancies.
• Support the preparation, coordination, and production of aggregate safety reports, including DSURs, PBRERs/PSURs, and other periodic or annual safety reports, as applicable.
• Coordinate operational activities and timelines associated with safety sections of regulatory submissions and responses to health authority requests.
• Work closely with Regulatory Affairs to maintain and implement applicable safety reporting requirements and reporting rules.
• Support pharmacovigilance activities associated with clinical study start-up, conduct, closeout, regulatory submissions, product launch, and post-marketing activities, as applicable.
• Maintain pharmacovigilance operational documentation, trackers, metrics, dashboards, and compliance reports and communicate relevant trends or risks to PV leadership.
• Support the development, maintenance, and implementation of pharmacovigilance Standard Operating Procedures (SOPs), work instructions, training materials, and other controlled documents.
• Assist with deviation investigations, corrective and preventive actions (CAPAs), and implementation of process improvements.
• Support pharmacovigilance inspection and audit readiness activities, including preparation and maintenance of documentation and responses to requests from auditors or health authorities.