Sr. Medical Director, Pharmacovigilance and Safety

Essential Duties

• Lead safety assessments, signal detection, and risk management activities for assigned products which include individual and aggregate data analyses; preparing signal assessments, guide cross functional teams to assess and interpret safety signals; preparing action and communication plans (written and verbal) to mitigate/manage product risks in collaboration with key stakeholders.
• Perform safety reviews in support of Data Monitoring Committee meetings.
• Maintain current level of expertise in safety related to gene therapy.
• Provide pharmacovigilance expertise to support full lifecycle drug development and study execution; represent Pharmacovigilance group at study execution and strategic forums.
• 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.
• 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 (Risk Management Plans, Post-Approval Safety Surveillance) to ensure safe and appropriate use of company products in compliance with global regulatory requirements.
• Address internal/external safety-related information 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 and BLA.
• 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.
• Support the development of standard operating procedures (SOPs) and/or other process related documents e.g. Safety Management Plans, Work Instructions.
• Active participant in inspection readiness activities, internal audits, and external inspections.
• 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.

Skill & Education Requirements

• MD, DO, or equivalent required, additional postgraduate training in neurology, pediatrics, and/or rare disease preferred but not required
• 10+ years of pharmacovigilance experience within the biopharmaceutical industry; other relevant experience may be considered.
• Experience as safety lead for development asset e.g. Global Safety Lead with responsibility for PV documents including but not limited to DSUR; RSI and ICF safety sections; risk management strategies and plans.
• Oversight experience of global medical safety activities including development asset 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), other electronic data capture systems, and MedDRA and WHO Drug coding and SAE reconciliation activities.
• 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.
• Ability to navigate fast paced and 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; organizational and prioritization skills a must.
• Demonstrate leadership and interact collaboratively and effectively in a team environment.
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Excellent communication skills and ability to influence multiple functions.
• International/domestic travel may be required.
• Natural fit with Taysha's Values of Integrity, Accountability and Teamwork.