Senior Medical Director, Pharmacovigilance and Safety

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🔥 9 minutes ago

🇺🇸 United States – Remote

💵 $325k - $375k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Taysha Gene Therapies

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Taysha Gene Therapies is a biotechnology company focused on developing innovative gene therapies for patients affected by diseases of the central nervous system (CNS), particularly those caused by single gene mutations, known as monogenic diseases. Their flagship program, TSHA-102, specifically targets Rett syndrome, a severe genetic disorder affecting females. With a dedicated team of experts and a commitment to impactful patient partnerships, Taysha aims to transform treatment options and improve the quality of life for individuals living with devastating CNS diseases.

📋 Description

• Lead safety assessments, signal detection, and risk management activities for assigned products • Conduct individual and aggregate data analyses and prepare signal assessments • Guide cross-functional teams in assessing and interpreting safety signals • Prepare action and communication plans to mitigate and manage product risks • Perform safety reviews supporting Data Monitoring Committee meetings • Maintain current expertise in gene therapy safety • Provide pharmacovigilance expertise throughout full lifecycle drug development and study execution • Represent Pharmacovigilance at study execution and strategic forums • Perform medical review of individual case safety reports, including coding, seriousness, expectedness, causality, medical interpretation, completeness, and accuracy • Review and draft queries and prepare or review analyses of similar events • Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and other functions on safety risk mitigation strategies • Address internal and external safety information requests from Health Authorities and Ethics Committees • Author and/or review aggregate safety reports including DSUR, PSUR, PBRER, PADER, IND Annual Reports, and BLA materials • Lead or contribute to Reference Safety Information, CCDS, CCSI, Investigator Brochure, and product labeling • Support development and maintenance of SOPs, Safety Management Plans, and Work Instructions • Participate in inspection readiness, internal audits, and external inspections • Maintain knowledge of PV regulations, regulatory guidance, Taysha SOPs, quality standards, and disease indications

🎯 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 a development asset, including responsibility for PV documents such as DSUR, RSI and ICF safety sections, and 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 the global pharmacovigilance regulatory environment, including FDA, EMA, and ICH guidelines and regulations • Working knowledge of ARGUS and ARISg safety databases, electronic data capture systems, MedDRA and WHO Drug coding, and SAE reconciliation • Excellent knowledge of the drug development process, clinical trial methodology, medical terminology, and principles of clinical assessment of adverse events • Experience reviewing cumulative safety data and interpreting, synthesizing, and communicating complex clinical/pharmaceutical information and safety data • Ability to develop risk management and mitigation strategies • Ability to navigate a fast-paced and dynamic work environment and manage multiple projects and demands simultaneously • Organizational, prioritization, communication, leadership, collaboration, and influencing skills • International/domestic travel may be required • Alignment with Taysha’s values of Integrity, Accountability, and Teamwork

🏖️ Benefits

• Individual Stock Option awards • ESPP program • Eligibility to participate in performance bonus program • Company-sponsored 401(k) with matching contribution • Medical, dental, vision, and prescription drug benefits • Generous vacation/holiday schedule • Remote work arrangement

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