Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.
The Director of Operations, Drug Safety and Pharmacovigilance (DSPV) will report to the Vice President, DSPV. The individual will be responsible for providing oversight and management of activities pertaining to Immunovant’s product safety and pharmacovigilance in clinical development and post-marketing surveillance.
The Director of Operations, DSPV will have responsibilities for pre- and post-marketing safety, PV and risk management activities. The incumbent in this position must effectively interface cross-functionally at all levels in the organization as well as with external regulatory authorities, contractors and vendors. The Director of Operations, DSPV oversees and is responsible for the integration of pre-and post-marketing safety surveillance with Clinical Development and Medical Affairs activities and for ensuring an integrated, proactive and compliant approach to risk management.
- Work with VP, DSPV to organize, manage and maintain a highly compliant Pharmacovigilance (PV) system for Immunovant
- Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of Immunovant products and to meet regulatory requirements.
- Participate in key activities of Drug Safety and Pharmacovigilance, including safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks
- Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues, including review of Investigator Brochures, clinical protocols, INDs/CTAs, regulatory responses, and risk management plans.
- Provide oversight and input to aggregate safety reports (e.g. development safety update reports, periodic benefit risk evaluation reports).
- Oversee serious adverse event handling, including individual case reviews, assessment of expectedness and relatedness, and collaboration with Regulatory on expedited reports, as appropriate.
- Provide input and ensure up-to-date Reference Safety Information, Company Core Data Sheets and product labeling
- Reconcile information in pharmacovigilance and clinical research databases.
- Participate in the drafting and implementation of pharmacovigilance contracts and agreements and oversee performance of Pharmacovigilance vendors.
- Support the recruitment, training, and professional development of DSPV personnel.
- Ensure audit and inspection readiness of the function at all times.
- Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities.
- Provide expertise on development of Standard Operating Procedures, Working Instructions and other guidance documents.
- Degree in medicine or in life sciences (e.g. Physician, Pharmacist, Nurse) or equivalent experience.
- 10+ years of relevant industry experience, including 4+ years of experience in Drug Safety and Pharmacovigilance
- Oversight experience of global medical safety activities, operations, and risk management strategies in pre and post marketing environments
- Demonstrated knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments
- Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels
- Experience with Individual Case Safety Reports, MedDRA coding, AoSE, and SMQs
- 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
- Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
- Skilled at people management including overseeing and controlling outsourced vendor activities in a compliance/regulated field.
- Strong knowledge and understanding of medical terminology and clinical development processes
- Rational approach to issues and their business implications, good problem solving and decision making skills.
- Highly analytical with the ability to give attention to detail.
- Dynamic, fast-paced, entrepreneurial and highly collaborative environment
- Immunovant’s headquarters is located in New York City. The position is flexible for remote work
- Domestic travel required (up to 10%)