We provide a competitive employee benefits package including pre-IPO stock options, flexible work options, discretionary time-off, comprehensive healthcare, and a 401k plan.
As the Lead, Global Safety and PV Operations you are responsible for safety/pharmacovigilance operational activities related to clinical and post-marketing use of Amylyx products. You will be accountable for the successful strategy, oversight, and execution of deliverables for the case management team (vendor) and ensuring individual adverse event case reports from all sources (spontaneous, literature, product/patient support programs, market research programs, clinical trials, medical information, call centers, health authorities, postmarketing commitment studies, etc.) are collected, managed and reported according to Amylyx SOPs and global adverse event regulations and guidelines. Reporting to the Head of Global Safety and Pharmacovigilance, you will manage contract service providers and ensure appropriate documentation is in place to support activities, including aggregate report production and compliance with timely reporting of safety information to Regulatory Authorities to meet regulatory requirements.
This role is critical to support Amylyx’s overall global safety surveillance program and the proper management of the benefit risk profile of our products, while ensuring compliance to global regulatory requirements and Amylyx’s policies and standards.
- Oversee and manage all operational aspects of drug safety and pharmacovigilance.
- Proactively oversee creation and continuous improvement of adverse event reporting and management processes on a global scale, including the oversight of the case management and regulatory submissions activities.
- Accountable for partnering with vendors for resolution of safety operational issues and questions, identifying vendor training needs and opportunities for improvement and ensuring implementation in collaboration with Amylyx stakeholders.
- Accountable for effective oversight of outsourced operational activities, measuring vendor performance through Key Performance Indicators/Metrics according to Amylyx standards and contracted Service Level Agreements(s).
- Oversee the appropriate management of safety data exchange agreements, (SDEA) safety management plans (SMP), and other operating procedures with business partners as required.
- Provide direction and leadership regarding safety vendor management.
- Assist in management of all critical departmental timelines and with budgets for internal and external spend.
- Plan and oversee the implementation of database reconciliation in collaboration with Data Management and Amylyx business partners as required.
- Ensure appropriate documentation by identifying and preparing required written procedures.
- Provide operational input into PV SOPs and reviews SOPs from other functions.
- Maintain aggregate report schedule, ensures proper SOPs are in place and current to support aggregate report production.
- In collaboration with Regulatory Affairs, provide information to be submitted to Regulatory Authorities, maintain, and update regulatory reporting rules, ensure timely submission of expedited safety reports, and ensure that submission information is tracked in the safety database.
- As required, participate in strategic planning, workflow development, standard operating procedure updates, development & compliance, audits, data analysis and clinical team meetings.
- Identify opportunities for process efficiencies and participate in process improvement initiatives.
- Provide support to Quality team and support product complaint activities as needed.
- Ensure compliance with FDA regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements.
- Bachelor’s degree in the life sciences or related area, Master’s degree or higher preferred.
- Minimum 8 years of pharmaceutical experience with a demonstrated focus in PV operations and compliance, and at least 4 years in a leadership role.
- Thorough knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines required, including Good Clinical Practices (GCP) guidelines.
- Thorough understanding of Individual Case Safety Reports (ICSR) processing operations required, including working with outsourced vendors and Contract Research Organizations as well as all steps through case receipt, case processing, medical review, and regulatory submission, issuing follow up queries, etc.
- Demonstrated technical, administrative, and project management capabilities.
- Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
- Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or more broadly within Amylyx.
- Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals in alignment with corporate goals.
- Proficient computer skills, including Microsoft Word, PowerPoint, and Excel.