Note: The job is a remote job and is open to candidates in USA. Amylyx Pharmaceuticals is a clinical-stage biotechnology company focused on developing treatments for diseases with high unmet needs, including post-bariatric hypoglycemia, Wolfram syndrome, and amyotrophic lateral sclerosis. The Senior Manager, Pharmacovigilance Operations will oversee day-to-day pharmacovigilance activities, including safety case processing, safety reporting, vendor management, data reconciliation, aggregate reporting, and continuous process improvement for clinical and marketed products.
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 escalate potential compliance issues to the Director, Pharmacovigilance Operations
- 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 escalate trends or performance concerns
- 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
- Participate in internal and external pharmacovigilance meetings and provide operational updates, metrics, risks, and recommendations
- Identify opportunities to improve the efficiency, quality, and scalability of pharmacovigilance processes and systems
- Support implementation and ongoing optimization of safety systems, tools, and technology used by the Patient Safety and Pharmacovigilance organization
- Maintain current knowledge of applicable global pharmacovigilance regulations, guidance, and industry best practices
- Perform other pharmacovigilance operational responsibilities as needed to support the evolving needs of the organization and portfolio
Skills
- * Degreed in a scientific, healthcare, nursing, pharmacy, or related discipline required and typically 7+ years of relevant pharmaceutical, biotechnology, CRO, or pharmacovigilance experience, or an equivalent combination of education and relevant experience; advanced degrees may substitute for some years of experience
- * Proficient with ICSR processing, expedited safety reporting, clinical trial safety activities, safety data reconciliation, and aggregate reporting processes
- * Experience providing operational oversight of internal client facing team or external pharmacovigilance vendors
- * Proficient in U.S. and global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, and applicable GCP requirements
- * Proficient with pharmacovigilance databases and safety systems; experience with Veeva Safety or similar platforms preferred
- * Experience supporting clinical-stage development programs required; experience with marketed products and post-marketing pharmacovigilance is a plus
- * Experience supporting pharmacovigilance audits and/or regulatory inspections
- * Demonstrated ability to manage multiple projects, timelines, and stakeholders while maintaining strong attention to quality and detail
- * Strong analytical and problem-solving skills with the ability to identify operational risks and recommend practical solutions
- * Excellent written and verbal communication skills
- * Ability to work effectively both independently and collaboratively within a cross-functional and highly matrixed environment
- * Comfortable working in a fast-paced, growing biotechnology organization where responsibilities may evolve as programs advance
- * At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee
- * You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested
- * You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location
- * Experience providing operational oversight of internal client facing team or external pharmacovigilance vendors strongly preferred
- * Proficient with pharmacovigilance databases and safety systems; experience with Veeva Safety or similar platforms preferred
- * Experience supporting pharmacovigilance audits and/or regulatory inspections preferred
Benefits
- Remote work opportunities within the United States
Company Overview