Associate Director, Pharmacovigilance Operations & Compliance - Travere Therapeutics : Job Details

Associate Director, Pharmacovigilance Operations & Compliance

Apply locations San Diego | time type Full time | posted on Posted 3 Days Ago | job requisition id R-100760

Department: 107400 Medical

Location: San Diego

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 Associate Director, Pharmacovigilance Operations & Compliance will be involved with pre- and post-marketing drug safety and pharmacovigilance activities. This role will oversee case processing activities, manage PV service providers, ensure timely safety report submissions in compliance with SOPs, guidelines, and regulations, and develop KPIs for compliance monitoring. The role includes leading PV inspection readiness activities and working cross-functionally within the organization and with external vendors.

• Lead oversight of daily operations with PV service providers, including procedural document development and maintenance
• Ensure adherence to global regulatory reporting timelines for safety reports
• Develop and monitor KPIs, compliance, and quality reviews
• Develop Quality Review programs for safety reports and documents
• Perform quality checks on safety reports and documents
• Oversee safety activities such as SAE reconciliations, vendor reconciliations, and submission compliance
• Manage safety activities involving business partners to ensure contract and agreement compliance
• Lead PV inspection readiness activities and manage audit preparedness
• Participate in regulatory inspections and audits
• Ensure compliance investigations and implement CAPA measures for deviations/quality events
• Oversee safety-related plans, including safety management and vendor oversight plans
• Manage PV project activities like safety meetings, timelines, and documentation archiving
• Support authoring or review of safety reports (e.g., PBRER, PADER, DSUR)
• Assist with vendor audits and inspections
• Support signal detection and risk management activities
• Contribute to PV SOPs, work instructions, and training materials; maintain documentation readiness
• Perform other duties as assigned

• Minimum 8+ years of PV experience in pharma/biotech or CRO, with at least 4 years in adverse event case management
• Experience with vendor oversight and safety case processing
• Bachelor's or higher in health/biomedical sciences or related field (e.g., RN, PharmD)
• Deep knowledge of FDA, EU, ICH guidelines, and global PV regulations
• Proficiency with MedDRA and safety systems (e.g., ARGUS, ARISg)
• Experience with audits and inspections preferred
• Strong interpersonal, communication, and proactive skills
• Ability to work independently and in teams
• Organizational, prioritization, and time management skills
• Ability to handle multiple projects simultaneously
• Problem-solving skills with a sense of urgency and attention to detail
• Proficiency in Word, Excel, PowerPoint

• Office and home environment
• Some travel (~10%), including weekends

Total Rewards Offerings: Travere offers comprehensive benefits including health, financial, work-life, and well-being programs, life insurance, disability, retirement plans with employer match, and generous paid time off.

Compensation: Our competitive package includes base pay, short-term incentives, and stock options. The target base pay range is $146,000 - $190,000, depending on experience and location.

Applications are accepted ongoing until the position is filled. Travere is an EEO/AA/Veteran/Disability Employer. For accommodations, contact [email protected].

Location: San Diego | posted on Posted 3 Days Ago