Senior Director, Safety and Pharmacovigilance

Overview

Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Senior Director, Safety and Pharmacovigilance reports to the Head of Clinical Development and will be responsible for leading Priovant's drug safety efforts and ensuring the safety of Priovant development programs throughout the lifecycle. This individual will play a key role in the success of Priovant's programs, with a focus on the upcoming NDA submission for brepocitinib in dermatomyositis. The ideal candidate will have a strong background in pharmacovigilance and safety science, with significant experience in autoimmune/inflammatory drug development and proven ability to lead safety strategy development and the creation of regulatory submissions.

Responsibilities

• Lead and oversee safety and pharmacovigilance activities, including risk management, safety assessments, signal detection, and regulatory compliance
• Serve as the safety expert on cross-functional teams, providing strategic direction and expert safety input
• Oversee and contribute to the development and submission of NDA/MAA safety sections and integrated safety summary (ISS)
• Collaborate with clinical development, clinical operations, regulatory affairs, and other teams to ensure alignment of safety strategies with program goals
• Lead safety data review and evaluation, including authoring or reviewing safety reports, regulatory submissions, and safety communications, as appropriate
• Ensure compliance with global pharmacovigilance regulations and standards including ICH, FDA, and EMA
• Represent Priovant in interactions with health authorities on safety-related matters including presenting safety data at regulatory meetings
• Represent Priovant at Investigator Meetings, scientific congresses, and interactions with key opinion leaders as appropriate
• Review incoming safety data from ongoing clinical trials
• Contribute to a culture of excellence and continuous improvement
• Occasional travel for study-related and company meetings
  
  

Qualifications

• MD or equivalent
• 5+ years experience in safety science and pharmacovigilance in drug development
• Strong knowledge of pharmacovigilance relevant to autoimmune/inflammatory diseases and small molecule therapies
• Direct experience with JAK inhibitor pharmacovigilance preferred
• Experience with NDA/MAA submissions and integrated safety summaries (ISS) preferred
• Experience working at a small biotech preferred
• Experience with large, global registrational trials preferred
• Natural collaborator with proven ability to succeed on cross-functional teams in a fast-paced, dynamic environment
• Ability to quickly assimilate technical and scientific information and consistently produce thorough and accurate work
• Hands-on, roll-up-your-sleeves approach, with a high sense of urgency and drive for results
• Demonstrated communication, problem-solving, and decision-making skills