Apply on Employer Site

Dianthus Therapeutics, Inc. · 1 month ago

Senior Manager, Pharmacovigilance

United States

Full-time

Remote

Senior Level

Dianthus Therapeutics is developing innovative therapies for patients with severe autoimmune diseases. The Senior Manager, Pharmacovigilance will play a crucial role in ensuring patient safety and regulatory compliance during clinical trials by managing safety data and collaborating with cross-functional teams.

BiopharmaBiotechnologyHealth Care

Responsibilities

Oversee pharmacovigilance activities for assigned clinical programs, ensuring alignment with global regulatory requirements and internal SOPs

Review, evaluate, and provide managerial oversight of adverse event (AE) reports, including serious adverse events (SAEs), ensuring accurate assessment and timely submission to regulatory authorities and ethics committees

Ensure quality and accuracy of safety data review within the safety database and direct reconciliation efforts with clinical databases to maintain data integrity

Contribute to the development of safety sections within clinical documents, including protocols, investigator brochures, and clinical study reports

Manage and oversee the scheduling, planning, and facilitation of DSMB and SRC meetings, including preparation of agendas, meeting materials, guided discussions, documentation of minutes, and follow-up on action items

Contribute strategically to the preparation of aggregate safety reports such as the DSUR

Partner with safety physicians on signal detection, emerging safety issues, risk assessments, and benefit–risk evaluations

Serve as a subject matter expert to internal stakeholders and external partners on safety-related topics, providing guidance and ensuring consistent communication

Ensure organizational compliance with global pharmacovigilance regulations (FDA, EMA, ICH) and company policies

Manage and oversee pharmacovigilance-related quality events, including change controls, deviations, and CAPAs, ensuring timely resolution and documentation

Supervise and ensure accurate documentation of DSMB and SRC meetings and maintain records within designated systems and repositories

Qualification

PharmacovigilanceAdverse event reviewGlobal PV regulationsArgus safety databaseClinical developmentMicrosoft Office SuiteMicrosoft TeamsAnalytical skillsStart-up experienceRare disease familiarityOncology programs familiarityOrganizational skillsCommunication skills

Required

Education: PharmD or RN degree required

Experience in pharmacovigilance or in clinical development within 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, with the ability to leverage these tools for efficient communication, scheduling, and documentation

Strong knowledge of global PV regulations (FDA, EMA, ICH guidelines)

Excellent analytical, organizational, and communication skills

Ability to thrive in a fast-paced, start-up environment and manage multiple priorities

Fluency with Argus safety database