Head, Global Safety and Pharmacovigilance

POSITION SUMMARY

The Head, Global Safety and Pharmacovigilance will lead the strategic management, planning, operations and execution of the Global Safety and Pharmacovigilance function for Amylyx products.   This person will be responsible for the development and compliance of the global pharmacovigilance system to ensure patient safety, full regulatory compliance, and timely flow of drug safety information from all sources, pre- and post-marketing, to clinical teams and senior management. You will work jointly with Clinical Development and Regulatory and provide oversight of drug safety for products in clinical development.

We are open to candidates in the United States, Canada, and Europe.

RESPONSIBILITIES

• Manage and lead the Safety and Pharmacovigilance department including oversight, operations and continuous growth.
  • Provide direction and leadership regarding safety vendors selection and management. 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). Recognize and escalate significant issues to ensure continuity of business objectives
  • Oversee the appropriate management of safety data exchange agreements, safety management plans, and other operating procedures with business partners as required. 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.
  • Collaborate with Amylyx team members on the development and implementation of safety and pharmacovigilance procedures (including SOPs, CAPAs, and third-party agreements) and documents used to provide training in Pharmacovigilance across the Company
  • Ensure inspection readiness for FDA or other regulatory agencies inspection activities related to safety and pharmacovigilance. Maintain safety inspection preparedness and ensure compliance with GCP and all applicable regulations. Support interactions and report, respond and resolve safety questions from the FDA, EMEA, and other regulatory authorities, and respond to regulatory agency audits.
  • Identify opportunities for process efficiencies and participate in process improvement initiatives

• Ensure compliance with health authority regulations in all aspects of case processing and reporting.
  • Execute EU Pharmacovigilance requirements including QPPV oversight.
  • Work with regulatory affairs to maintain and update regulatory reporting rules
  • Track compliance of expedited safety reports
  • Manage all signal detection and safety reporting activities, in partnership with external vendors, from all sources (spontaneous, literature, product/patient support programs, market research programs, clinical trials, medical information, call centers, health authorities, post marketing commitment studies, etc.) according to Amylyx’s SOPs and global regulations and guidelines.
  • Manage aggregate report production and ensure compliance with timely reporting. Content owner /author of relevant sections of investigational and marketed product pharmacovigilance related documents (e.g., DSUR, PBRER). Oversee, prepare, and review scheduled periodic/annual reports and INDs, IMPDs per local regulations.

• Lead Safety Review Meetings for company product(s). Provide strategic or operational input on project teams and interact with senior management to report project updates.
  • Collaborate with pre-clinical and clinical development to better assess and understand drug safety profiles Develop responses to health authorities regarding safety and pharmacovigilance.

• Oversee Safety Operations and reporting during clinical trials.
• Partner with clinical operations, regulatory affairs, clinical research organizations (CRO) and data management groups regarding safety data collection and data reconciliation for all clinical trials.  Point of contact for Safety risks identified by Medical Monitor.  Provide medical/clinical review of applicable Case Safety reports.  Oversee the resolution of safety queries.
• Contribute to Investigator’s Brochure (IBs); provide standardized safety language where required for informed consent forms (ICFs), study protocols, and other clinical documents as required.
• Plan and implement database safety reconciliations in collaboration with data management, compliance and CROs as required. 

REQUIREMENTS

• Minimum of 15+ years Safety / Pharmacovigilance experience in pre- and post- marketing environments with increasing responsibility of managerial oversight.
• MD or PharmD degree preferred. Board certification and/or experience in neurology indication(s) a plus.
• Excellent leadership qualities such as strategic thinking, people and resource management expertise.
• Demonstrated technical, administrative, and project management capabilities including: thorough understanding of Individual Case Safety Reports (ICSR) processing operations required, global pharmacovigilance regulatory environment with working knowledge of US and EU regulations, ICH guidelines, and a working understanding of common drug safety databases (e.g., Veeva).
• Effective project management skills with a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective.
• Ability to communicate complex clinical issues in a scientifically sound and understandable way.
• Experience working with all levels of management and consulting with key functions to influence greater outcomes.
• Skilled at negotiating with business partners and management and influencing senior level leaders regarding matters of significance to the department or, more broadly, the organization. Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve goals.