Senior Manager, Drug Safety & Pharmacovigilance

Department: 107500 Drug Safety & Pharmacovigilance

Location:

San Diego, USA
- Remote

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

The Senior Manager, Drug Safety & Pharmacovigilance (DSPV) will support pre- and post-marketing pharmacovigilance activities across both DSPV Operations and Safety Science. This position will be responsible for supporting day-to-day safety operations, including individual case safety report (ICSR) management, vendor oversight, regulatory reporting compliance, quality and compliance monitoring, and safety data reconciliation. The Senior Manager, DSPV will also support safety scientist activities, including medical review of ICSRs, clinical safety data review, signal detection and assessment, preparation and review of aggregate safety reports, review of safety information in clinical and regulatory documents, and contribution to risk management and product labeling activities.

• Manage the day-to-day pharmacovigilance operations performed internally and by PV service providers, including clinical trial and post-marketing case processing activities.
• Monitor compliance with global regulatory requirements and reporting timelines for expedited safety reports.
• Perform quality review of ICSR, safety documents to ensure completeness, accuracy, consistency, and regulatory compliance.
• Monitor PV vendor performance, including review of KPIs, compliance metrics, quality findings, and operational issues, and facilitate timely resolution and escalation as appropriate.
• Perform safety data reconciliations, including SAE reconciliation with clinical databases, vendor reconciliations, and other safety data reconciliation activities.
• Support PV activities involving business partners and licensing partners to ensure compliance with pharmacovigilance agreements, Safety Data Exchange Agreements (SDEAs), contracts, and applicable procedures.
• Support the development and maintenance of safety-related plans, including Safety Management Plans, Vendor Oversight Plans, and SAE Reconciliation Plans.
• Lead or coordinate investigation of PV deviations and quality events and drive the development, implementation, and effectiveness monitoring of corrective and preventive actions (CAPAs).
• Support PV inspection and audit readiness activities and maintain pharmacovigilance documentation in an inspection-ready state.
• Participate in regulatory inspections and internal or external audits involving pharmacovigilance, including preparation of requested documentation and responses to findings.
• Contribute to the development, revision, and implementation of PV SOPs, Work Instructions, procedural documents, and training materials.
• Support departmental project management activities, including safety team meetings, tracking deliverables and timelines, meeting documentation, and appropriate archiving of PV records.

• Perform medical review of ICSR from clinical trials and post-marketing sources, including review of adverse event coding, seriousness, expectedness, causality, narratives, listedness, and overall case quality.
• Contribute to ongoing medical and safety review of clinical study data and identify safety findings, trends, inconsistencies, or potential issues requiring further evaluation.
• Review MedDRA coding and other safety-related coding of clinical and post-marketing data, as appropriate.
• Contribute to the planning, preparation, authoring, review, and…