Organizational Overview:

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Role:

Reporting to the Vice President, Drug Safety and Pharmacovigilance (DSPV), this position is responsible for providing oversight and management of activities pertaining to Immunovant’s product safety and pharmacovigilance. The individual in this role must work effectively with medical and operations personnel in DSPV, and cross-functionally at all levels in the organization, to ensure a robust, proactive, and compliant approach to product safety evaluation, safety reporting, and risk management.

Key Responsibilities: 

• Provide PV subject matter expertise at cross-functional meetings and serve as a key analytic and safety support lead in close collaboration with the VP and Senior Medical Directors in DSPV.
• Perform and/or oversee signal management activities including – signal detection, analysis, and tracking for Immunovant products.
• Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities, and develop strategies for safety assessment in collaboration with the VP and Senior Medical Directors in DSPV
• Participate in risk management planning and benefit-risk assessments.
• Plan and participate in Safety Review Committee (SRC); may include developing agendas, slide creation, data presentation, and recording minutes.
• Lead in the planning and writing of periodic safety reports (e.g., DSUR, PBRER).
• Contribute to and/or lead Sponsor medical review of ICSRs (narratives, coding, expectedness, causality, and seriousness) to ensure quality reports.
• Contribute to response documents for Health Authority and EC/IRB requests.
• Contribute to safety sections of clinical documents including investigator’s brochure, clinical study protocols, informed consent forms, clinical study reports, development core safety information, and development risk management plans.
• Collaborate with DSPV Operations, Clinical Operations, Data Management, Biostatistics, Clinical CRO, and Study Teams to generate Safety deliverables (e.g. data tables, figures and listings for Signal Detection Reports, Data Monitoring Committee reviews, and DSURs).
• Support DSPV Operations, as needed, to ensure timely processing and compliant reporting for all SAEs from assigned protocols.
• Keep updated on relevant regulations associated with the above activities.
• Participate in development, implementing, and maintaining processes for safety surveillance, such as developing standard operating procedures and templates, that are compliant with global PV regulations.
• Contribute to inspection readiness and support audits/inspections.

Requirements:

• Degree in life/health sciences field (e.g. MD, PharmD, BSN, BS/BA in Biology, Chemistry, or other life science).
• Minimum 4-6 years of relevant industry experience (medical, scientific/clinical, or pharmaceutical), including 3 years of experience in drug safety/pharmacovigilance serving in a PV scientist role.
• Demonstrated knowledge of relevant global guidelines, initiatives, and regulations (FDA, EU, ICH) governing safety surveillance activities for clinical trial environments.
• Experience in signal detection activities with demonstrated experience in analysis and interpretation of medical and scientific data.
• Experience in aggregate safety assessment and reporting (e.g. DSUR, Signal Detection)
• Working knowledge of Risk Management requirements and activities.
• Knowledge of MedDRA terminology structure and its application, including development of coding and search strategies, and common knowledge of common safety database systems (Argus).
• Ability to communicate complex clinical issues in a scientifically sound and understandable way.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team.
• Strong interpersonal skills including verbal and written communication.
• Knowledge of global device safety regulations, as well as experience in device safety surveillance, is advantageous.

Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Limited domestic or international travel may be required (<10%)