What are the responsibilities and job description for the Manager / Senior Manager, Drug Safety Operations position at Dianthus Therapeutics, Inc.?
About Us
We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.
About the Role
As the Manager / Senior Manager, Drug Safety Operations, you will help lead and optimize operational aspects of pharmacovigilance across multiple clinical programs.
You will be responsible for vendor relationships, ensuring compliance with global safety regulations, and managing critical processes that support patient safety and regulatory reporting. Experience with pharmacovigilance-related quality events including change control, deviations, and CAPA management and compliance reports is preferred.
This is a unique role that will allow you to work independently and also contribute to a growing pharmacovigilance team that is working closely with cross functional teams to help Dianthus elevate the care of our patients' lives. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives. We are open to you working remotely.
Key Responsibilities
We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.
About the Role
As the Manager / Senior Manager, Drug Safety Operations, you will help lead and optimize operational aspects of pharmacovigilance across multiple clinical programs.
You will be responsible for vendor relationships, ensuring compliance with global safety regulations, and managing critical processes that support patient safety and regulatory reporting. Experience with pharmacovigilance-related quality events including change control, deviations, and CAPA management and compliance reports is preferred.
This is a unique role that will allow you to work independently and also contribute to a growing pharmacovigilance team that is working closely with cross functional teams to help Dianthus elevate the care of our patients' lives. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives. We are open to you working remotely.
Key Responsibilities
- Vendor Oversight:
- Manage and oversee safety vendors responsible for case processing and related pharmacovigilance activities.
- Ensure vendor compliance with contractual obligations, timelines, and quality standards.
- Operational Management:
- Oversee case processing activities, including intake, triage, and timely reporting of adverse events.
- Maintain and monitor trackers for lab values and other safety-related data to ensure accurate and timely updates.
- Manage pharmacovigilance agreements (PVAs) with partners and ensure alignment with regulatory requirements.
- Safety Database Management:
- Oversee the configuration, maintenance, and quality control of the safety database.
- Ensure accurate data entry, reconciliation with clinical databases, and timely generation of safety reports.
- Cross-Functional Collaboration:
- Build strong relationships with internal stakeholders (clinical operations, regulatory, medical) and external partners.
- Provide operational expertise during audits and inspections.
- Compliance & Documentation:
- Ensure adherence to global PV regulations (FDA, EMA, ICH) and company SOPs.
- Manage pharmacovigilance-related quality events including change control, deviations, and CAPAs.
- Manage PV-related Key Performance Indicators (KPI) metrics system and reporting methods.
- Bachelor's degree in life sciences or related field required; advanced degree preferred.
- Minimum 7 years in drug safety/pharmacovigilance operations within biotech or pharmaceutical industry.
- Proven experience managing safety vendors and overseeing case processing activities.
- Hands-on experience with pharmacovigilance agreements and safety database management.
- Strong knowledge of global PV regulations and GVP guidelines.
- Excellent organizational, communication, and vendor management skills.
- Ability to thrive in a fast-paced, start-up environment.
