Vice President, Global Patient Safety & Pharmacovigilance
Remote
Full Time
Experienced
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: Vice President, Global Patient Safety & Pharmacovigilance
Reports to: Chief Medical Officer
Office Location: Remote
Overview of Position:
Reporting to the Chief Medical Officer, the VP Global Patient Safety & Pharmacovigilance (GPS), will provide clinical/scientific/pharmacovigilance expertise to lead signal detection, benefit-risk evaluation, and risk management activities in support of Taysha’s products throughout their lifecycle. This includes the development of processes to support proactive identification, evaluation, and risk management of safety risks for assigned Taysha products. This individual will lead surveillance activities from various sources including pre-clinical studies, clinical studies, scientific literature and other sources. This individual will also contribute to a full range of pharmacovigilance activities including but not limited to GPS department organization and infrastructure development. In addition, she/he will also function in a company matrix environment collaborating with several key groups including Translational Sciences, Clinical Operations, Biometrics, Data Management, Clinical Development, Regulatory Affairs, Medical Affairs, Medical Writing, and Quality Assurance.
Essential Duties & Responsibilities
Minimum Qualifications (Education & Experience)
Preferred Qualifications
The level of this position will be based on the final candidate’s qualifications.
Please 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.
Position: Vice President, Global Patient Safety & Pharmacovigilance
Reports to: Chief Medical Officer
Office Location: Remote
Overview of Position:
Reporting to the Chief Medical Officer, the VP Global Patient Safety & Pharmacovigilance (GPS), will provide clinical/scientific/pharmacovigilance expertise to lead signal detection, benefit-risk evaluation, and risk management activities in support of Taysha’s products throughout their lifecycle. This includes the development of processes to support proactive identification, evaluation, and risk management of safety risks for assigned Taysha products. This individual will lead surveillance activities from various sources including pre-clinical studies, clinical studies, scientific literature and other sources. This individual will also contribute to a full range of pharmacovigilance activities including but not limited to GPS department organization and infrastructure development. In addition, she/he will also function in a company matrix environment collaborating with several key groups including Translational Sciences, Clinical Operations, Biometrics, Data Management, Clinical Development, Regulatory Affairs, Medical Affairs, Medical Writing, and Quality Assurance.
Essential Duties & Responsibilities
- Provide dynamic leadership, strategic direction and governance of patient safety and pharmacovigilance risk management activities across Taysha’s portfolio.
- Lead signal detection and risk management activities for assigned products which includes individual and aggregate data analyses; prepare signal assessment, track and validate documents; lead cross functional teams to assess and interpret safety signals; prepare action and communication plans (written and verbal) to mitigate/manage product risks in collaboration with key stakeholders.
- Partner with internal stakeholders to establish the DMC strategy across the portfolio and lead safety reviews in support of DMC meetings.
- Responsible for developing expertise in gene therapy, with continuous knowledge acquisition and education regarding current safety matters relating to gene therapy.
- Lead proactive and ongoing assessment of pre-clinical, clinical, scientific literature, and other data to inform safety strategy and ensure positive benefit-risk profile for assigned programs in collaboration with key stakeholders.
- Provide pharmacovigilance expertise to support full lifecycle drug development and study execution; represent Pharmacovigilance group at study execution and strategic forums.
- Review of individual and aggregate AEs, prepare safety reports, and communicate changes in the product risk profile to internal and external stakeholders.
- Perform individual case safety report (ICSR) medical review to ensure accurate medical coding, seriousness, expectedness and company causality assessment, ensure appropriate medical interpretation, completeness, and accuracy of information, review and draft queries, and prepare or review the analysis of similar events (AOSE) as required.
- Responsible for the identification, evaluation, validation, and communication of possible adverse event trends for products including individual and aggregate data analyses.
- Lead multidisciplinary Global Safety Committees (GSC) whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations regarding communication plan and labeling, as appropriate.
- Collaborate with cross functional teams, including Clinical Development, Regulatory Affairs, Biostatistics, and other functional areas to design, evaluate, implement, and oversee safety risk mitigation strategies (REMS, Risk Management Plan, Post-Approval Safety Surveillance) to ensure safe and appropriate use of company products in compliance with global regulatory requirements.
- Address internal/external safety-related requests, including questions from Health Authorities and/or Ethics Committees (both written and verbal).
- Author and/or review pre- and post-marketing aggregate safety reports including DSUR, 6-monthly line listing reports, PSUR, PBRER, PADER, IND Annual Reports.
- Actively participate in inspection readiness activities, internal audits, and external inspections.
- Develop training materials and conduct training on PV related content, including presentations at Investigator Meetings or Site Initiation Visits, as needed.
- Review medical/scientific literature to support signal detection activities and aggregate reporting for products.
- Contribute to the development and review of clinical, regulatory, and scientific documents including protocols, informed consent forms, clinical study reports, manuscripts/journal articles, case report forms, statistical analysis plans, integrated summaries of safety (ISS), New Drug or Biologic License Applications (NDA/BLA), and/or other documents as needed, ensuring safety content is harmonized.
- Develop or support development of standard operating procedures (SOPs) and/or other process related documents e.g. Safety Management Plans, Work Instructions.
- Contribute to vendor governance activities and oversight of key performance indicators.
- Lead and/or 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.
- Provide oversight and support for MedDRA and WHODrug coding and SAE reconciliation activities.
- Participate in the development of PV organizational strategy, goals, and objectives and assist with implementation and training to support department goals and initiatives.
- Maintain knowledge of new PV/safety regulations and guidance from regulatory authorities, Taysha SOPs, and quality standards.
- Maintain knowledge of disease indications for assigned investigational and/or marketed products.
- Support hiring, orientation, management, mentorship, and development of PV team.
Minimum Qualifications (Education & Experience)
- MD required.
- 10+ years of pharmacovigilance experience; other relevant experience may be considered.
- Experience as safety lead for asset/approved drug product e.g. Global Safety Lead with responsibility for PV documents including but not limited to DSUR/PBRER; IB and ICF safety sections; risk management strategies and plans.
- Oversight experience of global medical safety activities including asset / approved product level safety governance, operations and risk management strategies in pre and post marketing environments.
- Demonstrated knowledge of global PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EMA, 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.
- Knowledge of MedDRA dictionary with relevance to adverse event coding.
- Excellent knowledge of drug development process, including clinical trial methodology, medical terminology and general principles of clinical assessment of AEs.
- Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data and developing risk management/mitigation strategies.
- Experienced in supporting PV audits and/or health authority inspections.
- Ability to navigate fast-paced, dynamic work environment; ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure.
- Demonstrates leadership and interacts collaboratively and effectively in a team environment (e.g. Clinical Operations, Clinical Science, Data Management, Medical Affairs) and with external vendors and stakeholders.
- Excellent communication skills and ability to influence across multiple functions.
- International/domestic travel may be required.
- Good culture fit with Taysha’s Core Values:
- Integrity
- Accountability
- Teamwork
Preferred Qualifications
- MD Board certification
- Experience in cell or gene therapy; experience in other serious conditions, including oncology, rare or fatal conditions will be considered.
The level of this position will be based on the final candidate’s qualifications.
Please 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.
Apply for this position
Required*