Job Description
Title: (Senior) Medical Director / Director, Drug Safety & Pharmacovigilance
Location: Remote
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
The (Senior) Medical Director/Director of 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 (Senior) Medical Director/(Director), 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. The (Senior) Medical Director/Director, 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 and proactive approach to risk management.
Key Responsibilities:
Provide medical and scientific expertise in all aspects of Drug Safety and Pharmacovigilance, including safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks
Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment and clinical trial data interpretation
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 contributing authorship and review of Investigator Brochures, development plans, 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.
Support internal PV Operations function.
Support the recruitment, training and professional development of DSPV personnel.
Oversee drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizations
Ensure audit and inspection readiness of the function at all times
Provide expertise on development of Standard Operating Procedures, Working Instructions and other guidance documents.
Requirements:
MD or other advanced degree in health sciences field (e.g. PharmD, BSN)
5+ years of relevant industry experience, including 3+ 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
Experience with global regulatory filings
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 MedDRA coding, AoSE, and SMQs
Excellent clinical judgment and 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
Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
Work Environment:
Remote-based
Dynamic, interactive, fast-paced, and entrepreneurial environment
Domestic or international travel are required (10-20%)