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Associate Director, Pharmacovigilance

2 weeks, 6 days ago
United States
Full-time
Lead
Operations Specialist
Operations
Apply Now
Dianthus Therapeutics

Dianthus Therapeutics

Dianthus Therapeutics is focused on developing advanced complement antibody therapeutics, specifically engineered to provide targeted treatment for patients with significant unmet medical needs, exemplified by their lead product, claseprubart (DNTH103)...

Pharmaceuticals
11-50
Founded 2019
View All Jobs 6

Description

  • Oversee pharmacovigilance activities for assigned clinical programs in alignment with global regulatory requirements and internal SOPs.
  • Review and manage adverse event and serious adverse event reports, ensuring accurate assessment and timely regulatory submission.
  • Maintain high-quality safety data review in the safety database and reconcile safety data with clinical databases.
  • Contribute to safety sections of clinical documents such as protocols, investigator brochures, and clinical study reports.
  • Schedule, plan, and facilitate DSMB and SRC meetings, including agendas, materials, minutes, and action-item follow-up.
  • Contribute to aggregate safety reports, including DSURs.
  • Partner with safety physicians on signal detection, emerging safety issues, risk assessments, and benefit-risk evaluations.
  • Serve as a subject matter expert for internal stakeholders and external partners on safety-related topics.
  • Ensure compliance with global pharmacovigilance regulations and company policies.
  • Manage pharmacovigilance quality events such as change controls, deviations, and CAPAs, and maintain meeting documentation in designated systems.

Requirements

  • PharmD or RN degree is required.
  • Experience in pharmacovigilance or clinical development within the biotech or pharmaceutical industry.
  • Proven experience reviewing adverse events and working closely with safety physicians.
  • Hands-on experience supporting DSMBs and SRCs and preparing safety deliverables.
  • Proficiency in Microsoft Office Suite and Microsoft Teams.
  • Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines.
  • Fluency with the Argus safety database.
  • Excellent analytical, organizational, and communication skills.
  • Ability to thrive in a fast-paced, start-up environment and manage multiple priorities.
  • Familiarity with rare disease or oncology programs is preferred.
  • Prior experience in a start-up or small biotech setting is preferred.

Benefits

  • Remote work available within the United States.
  • Opportunity to work with a growing pharmacovigilance team in a mission-driven biotech environment.
  • Work on a pipeline focused on severe autoimmune diseases and patient-friendly therapies.

Interested in this position?

Apply directly on the company website

Apply Now

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