Global Safety Director

4 days ago

Dallas, Texas, United States Taysha Gene Therapies Full time
About the Opportunity

This is an exciting opportunity for a seasoned pharmacovigilance professional to join our team at Taysha Gene Therapies. As the Director, Global Patient Safety & Pharmacovigilance Operations, you will play a critical role in ensuring the safe development and commercialization of our gene therapies. You will work closely with cross-functional teams to develop and implement proactive risk management strategies, manage safety reports and data, and ensure compliance with global regulations.

Responsibilities
  1. Risk Management Strategies: Develop and implement proactive risk management strategies for marketed and/or investigational compounds, working closely with cross-functional teams.
  2. Safety Report Management: Ensure that safety reports for assigned products are triaged, processed, and submitted/distributed as required per global requirements and applicable SOPs.
  3. Reference Safety Information: Contribute to the development and maintenance of Reference Safety Information (RSI) including Company Core Data Sheet (CCDS), Company Core Safety Information (CCSI), Investigator Brochure (IB), and/or other product labeling.
  4. Periodic Safety Reports: Contribute to writing and review of periodic safety reports e.g. Development Safety Update Reports (DSUR), 6-monthly line listing reports or other aggregate safety reports and oversee reporting compliance.
  5. Safety Database Management: Perform and/or provide oversight for day-to-day interaction with PV vendor(s) and communicate with partner companies, vendors, and internal group regarding processing and timely exchange of safety reports.
  6. Clinical and Regulatory Documents: Contribute to the development and review of clinical, regulatory, and scientific documents including clinical study protocols, informed consent forms, study plans, clinical study reports, manuscripts/journal articles, case report forms, statistical analysis plans, and/or other documents.
Requirements
  • Bachelor's level degree with advanced degree preferably in scientific field; Healthcare professional degree preferred (Nurse Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent).
  • 10 years of experience in pharmaceuticals/biotech with at least 5 years direct PV Operations experience.
  • Demonstrated knowledge of global PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EU, GVP, ICH guidelines and regulations pertaining to clinical development and post-marketing safety environments.
  • Working knowledge of industry standard safety databases (ARGUS and ARISg) and other electronic data capture systems.
  • Experience with safety database migration.
  • Excellent knowledge of drug development process.
  • Knowledge of MedDRA dictionary, clinical trial methodology, medical terminology, and general principles of clinical assessment of AEs .
  • Experienced in supporting PV audits and/or health authority inspections.
  • Ability to navigate fast-paced and dynamic work environment; ability to manage and prioritize multiple projects and demands simultaneously and adjust quickly to changing priorities.
  • Excellent communication, interpersonal, and writing skills, including ability to work effectively globally and cross-functionally.
  • Strong organizational and project management skills.
  • EudraVigilance certified.
  • Rare Disease/Gene Therapy experience, preferred.

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