Sr. Manager, DSPV Operations | IMVT Corporation | Remote (USA)

Sr. Manager, DSPV Operations | IMVT Corporation | Remote (USA)

Remote US
Application ends: September 19, 2024
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Job Description

Organizational Overview:

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 Role:

The Senior Manager of Operations, Drug Safety and Pharmacovigilance (DSPV) will report to the Director/Senior Director of Operations, DSPV. This role will be primarily responsible for proactively managing safety activities outsourced to safety vendors for all Immunovant products (investigational and marketed), including case management, submissions, safety plan development, and overall vendor performance/compliance. The incumbent in this position must effectively interface with all vendors supporting safety activities and ensure that all safety deliverables are performed on time and in accordance with applicable regulations and agreements.  

Key Responsibilities:

  • Work with Senior Director, DSPV to organize, manage and maintain a highly compliant Pharmacovigilance (PV) system for Immunovant.
  • Serves as additional point of contact with safety vendor managing routine activities and addressing related issues.
  • Assist with evaluating ICSR reports received from the case processing vendor for accuracy and regulatory reporting, provide feedback as necessary.
  • Exercises independent judgment in managing case processing PV deliverables and maintaining compliance with internal SOPs and project-related documentation.
  • Assist and/or lead the creation and/or maintenance of key safety documentation with the safety vendors (e.g., safety management plans, safety reporting plans, etc.).
  • Assist with post-authorization safety planning activities.
  • Works effectively with internal and external stakeholders at all levels on relevant PV deliverables or initiatives.
  • May participate in various key activities of Drug Safety and Pharmacovigilance, including safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks.
  • Assist with aggregate safety reports as necessary (e.g., development safety update reports, periodic benefit risk evaluation reports).
  • Oversee the reconciliation of information in pharmacovigilance and clinical research databases.
  • Support audit and inspection readiness activities.
  • Support development of Standard Operating Procedures, Working Instructions and other guidance documents.
  • Support adherence to relevant regulatory requirements and company Standard Operating Procedures as appropriate.
  • Support drafting and review of internal and external Quality Documents, including any Deviations, CAPAs and Change Controls
  • Perform other tasks and assignments as needed and specified by management.

Requirements:

  • Degree in medicine or in life sciences (e.g., Physician, Pharmacist, Nurse) or equivalent experience.
  • 4+ years of experience in Drug Safety and Pharmacovigilance.
  • Knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing safety reporting and case processing activities for clinical trial environments.
  • Experience with Individual Case Safety Reports and MedDRA coding.
  • 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 relevant FDA and International Conference on Harmonisation (ICH) guidelines, including Good Clinical Practices (GCP) guidelines.
  • Experience with vendor management, including overseeing and controlling outsourced vendor activities in a compliance/regulated field.
  • Strong knowledge and understanding of medical terminology.
  • Rational approach to issues and their business implications, good problem solving and decision-making skills.
  • Highly analytical with strong attention to detail.

Work Environment:

  • Dynamic, fast-paced, entrepreneurial and highly collaborative environment
  • Immunovant headquarters is located in New York City. The position is flexible for remote work
  • Domestic travel may be required (up to 10%)