Organizational Overview:

Immunovant is a clinical-stage biopharmaceutical company with a company vision focused on enabling normal lives for patients with autoimmune diseases. Our lead asset, IMVT-1401, is a novel, fully-human, anti-FcRn monoclonal antibody in clinical development for multiple indications, delivered as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. Immunovant is committed to developing innovative therapies that not only treat the symptoms but modify the course of autoimmune diseases, while restoring hope and health to patients with autoimmune disease by developing and delivering high-value restorative therapies that enable them to live normal lives.

The Role:

This is a key position in the Drug Safety and Pharmacovigilance (DSPV) organization and is responsible for conducting DSPV operational activities including maintaining compliance, preparation of aggregate reports, signal detection activities, managing standard DSPV procedures, and oversight of vendor services and DSPV personnel, and DSPV agreements. This role is critical to support the overall safety surveillance program and ensure the proper management of the benefit-risk profile.

Key Responsibilities:

Oversees and manages operational aspects of drug safety and pharmacovigilance
Work with and effectively manages cross-functional team members to ensure accurate and efficient safety data collection from clinical trials
Ensure compliance with FDA regulations and ICH guidelines to meet global regulatory drug safety and pharmacovigilance reporting requirements
Oversight of pharmacovigilance service vendors
Assist in production and revision of clinical trial documents and report forms
Assist in safety review, data reconciliation, and signal evaluation activities
Search and retrieve safety data from safety and clinical trial databases for inclusion in external and internal reports
Draft aggregate data summaries for medical review
Responsible for periodic safety and clinical study report processes and documents
Assist in GCP and GVP inspection readiness and conduct
Provides PV input as an ad hoc study team member
Maintains company Reference Safety Information in line with company medical opinion
Oversee development of global SOPs and policies to ensure compliance with regulatory requirements
Work with quality assurance colleagues to address safety-related GCP compliance issues and implement corrective action
Identify opportunities for process efficiencies and participate in process improvement initiatives

Requirements:

Bachelor’s degree in the life sciences or related area; Advanced degree preferred
Minimum 10 years of pharmaceutical experience with a demonstrated focus in PV operations and compliance
Working knowledge of validated drug safety databases and MedDRA
Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
Thorough understanding of Individual Case Safety Reports (ICSR) processing operations, including working with outsourced vendors and Contract Research Organizations
Demonstrated technical, administrative, and project management capabilities
Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills
Adaptable to changing priorities
Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or more broadly within the company
Adept at creating and communicating a clear vision, effectively aligning resources to achieve functional area goals in alignment with corporate goals
Effective communication skills with direct reports, leads by example, and able to positively motivate direct reports taking into account career paths
Proficient computer skills, including Microsoft Word, PowerPoint and Excel
Comfortable working independently with minimal supervision
Knowledge of pharmacovigilance regulations and guidelines
Demonstrated understanding of safety database, medical literature and electronic data capture technology
Highly organized, results driven, problem solver
Superior written and oral communication skills and the ability to work with different levels of management in several departments
Highly motivated with the ability to be flexible in a fast-paced environment
Effective leadership skills
May have more than one direct report