Job Description
Company 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.
Position Title: Director, Global Patient Safety & Pharmacovigilance Operations
Reports to: VP, Global Patient Safety & Pharmacovigilance
Location: Dallas, TX; Durham, NC; Remote
Overview of Position The Director, Global Patient Safety & Pharmacovigilance Operations, will contribute to a full range of pharmacovigilance activities including but not limited to the oversight and management of safety reports and safety data, signal management activities, PV organization and process development, inspection readiness, PV vendor management, and operational support for all Taysha products throughout the lifecycle. In addition, she/he will also function in a company matrix environment collaborating with several key groups including Clinical Operations, Biometrics, Data Management, Clinical Development, Regulatory Affairs, Medical Writing, and Clinical/Nonclinical Compliance.
Essential Duties - 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 group 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.
- Support organizational leadership in assigned activities and initiatives and actively participate in daily pharmacovigilance activities with a "can-do, hands-on, positive attitude.”
Skill & Education 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.
Base compensation range at time of posting: $190,000 – 220,000
The actual base salary depends, in part, on the successful candidate’s qualifications for the role, including education and experience. Tysha offers a comprehensive compensation and benefits program to eligible employees, 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.
Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Taysha is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Taysha are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.
Job Tags
Holiday work, Full time,