Global Pharmacovigilance Operations Lead

2 days ago

Dallas, Texas, United States Taysha Gene Therapies Full time
Job Overview

Taysha Gene Therapies is a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations.

Compensation Package

The estimated base salary range for this position is $190,000 to $220,000. In addition to competitive compensation, Taysha offers a comprehensive benefits package, including Individual Stock Option awards; ESPP program; eligibility to participate in performance bonus program; company-sponsored 401(k) with matching contribution; eligibility for medical, dental, vision and prescription drug benefits and a generous vacation/holiday schedule.

Job Responsibilities
  • Develop proactive risk management strategies for marketed and/or investigational compounds.
  • Participate in departmental and cross-functional risk assessment and process improvement initiatives.
  • Ensure that safety reports for assigned products are triaged, processed, and submitted/distributed as required per global requirements and applicable SOPs.
  • 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.
  • 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.
  • Assist in SAE reconciliation activities.
  • Communicate with partner companies, vendors, and internal groups regarding processing and timely exchange of safety reports.
  • Perform and/or provide oversight for day-to-day interaction with PV vendor(s).
  • 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.
  • Develop training materials and conduct training on PV Operations related content, including presentations at Investigator Meetings or Site Initiation Visits.
  • Maintain knowledge of disease indications for assigned investigational and/or marketed Taysha products.
  • Represent PV in program teams or similar meetings for assigned products.
  • Participate in the development of PV Operation strategy, goals, and objectives and assist with the implementation and training to support department goals and initiatives.
  • Develop or support development of standard operating procedures (SOPs) and/or other process related documents e.g. Safety Management Plans, Work Instructions.
  • Develop templates, trackers, and other tools to aid in oversight and/or standardization of PV processes.
  • Review key performance indicators in support of pharmacovigilance quality and vendor oversight.
  • Support inspection readiness and compliance activities including organizing and preparing materials in support of audits and inspections; developing compliance reports and tracking of compliance metrics, internal/external Corrective Action and Preventative Actions (CAPA) management as needed; assisting in the identification and follow-up of corrective actions arising from audits and/or inspections.
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.
  • Occasional international/domestic travel may be required.
  • EudraVigilance certified.
  • Rare Disease/Gene Therapy experience, preferred.

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