Senior Drug Safety and Pharmacovigilance Specialist

Department: 107500 Drug Safety & Pharmacovigilance –

Location:

San Diego.

At Travere Therapeutics, we are a dedicated team focused on meeting the unique needs of patients living with rare diseases. We seek talented individuals to support the Drug Safety and Pharmacovigilance team in ensuring compliance with FDA and global safety reporting requirements.

• Management of Travere’s drug safety mailboxes, including archiving emails and documents.
• Assist in the review of individual case safety reports (ICSRs) for accuracy and quality.
• Track ICSR data from clinical studies and post‑market cases and ensure timely submission to applicable regulatory authorities and business partners, including distribution to IRBs/Ethics Committees for expedited safety reporting cases.
• Assist with AE/SAE reconciliation activities using all data sources such as clinical trials, business partners, and the call center.
• Maintain oversight and assist with query management, including review, approval of queries and timely closure of follow‑up requests.
• Coordinate with vendors to ensure all internal and external timelines are met, potential issues are communicated, and resolution is achieved promptly.
• Develop safety report forms for clinical trials and post‑market, such as study‑specific safety report forms, pregnancy report forms, and post‑market AE report forms.
• Create and maintain study‑specific Safety Management Plans (SMP) and configure the safety database for each study.
• Participate in Study‑Management Team (SMT) meetings as required and elevate AE management issues.
• Assist with vendor oversight for processing adverse event data in compliance with applicable global regulations, internal SOPs, and SMPs.
• Review Safety Report Forms to ensure consistency in initial evaluation and assessment of reports and source documentation.
• Support the development and implementation of PV‑related guidelines, work instructions, SOPs, and ensure uniform and timely processing of adverse event data.
• Support the planning and preparation of aggregate safety reports such as Periodic Safety Reports, periodic line listings, etc., as assigned.
• Support safety signal management activities, including literature search and review.
• Support and participate in inspection readiness activities.
• Maintain understanding and ensure compliance with pharmacovigilance SOPs, work instructions, global regulations (FDA, EU Directives), GxPs, and ICH guidelines.
• Other responsibilities as assigned.

• Bachelor’s degree in a related Life Sciences discipline (RN, PharmD, PA preferred).
• Minimum four (4) years of relevant drug safety and pharmacovigilance experience at a biotech, pharmaceutical, or CRO company.
• Knowledge of GVP, GCP, US and EU regulations and guidelines, and other international regulatory requirements.
• Knowledge of the MedDRA dictionary relevant to AE/SAE coding.
• Proficiency using safety databases (e.g., Argus, ARISg) and familiarity with clinical trial databases (e.g., Medidata Rave).
• Strong interpersonal and organizational skills and excellent verbal and written communication skills.
• Self‑motivated, well‑organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross‑functional teamwork environment.
• Ability to work both independently and as part of a team.
• The ideal candidate will embody Travere’s core values:
  Patient‑Inspired, Courageous, Promote Community, Stronger Together.
• Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Ability to work effectively in both office and remote work environments.
• Some travel (10%) may be required, potentially including weekend travel.

Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people‑centric, and pay‑for‑performance organization. Benefits include premium health, financial, work‑life and well‑being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability coverage, retirement plans with employer match, and generous paid time off.

Competitive compensation includes a combination of cash compensation (base pay and short‑term incentive) and long‑term incentive compensation (company stock). Target base pay range: $95,000.00 – $ (as of posting date; may be modified).

Travere is an EEO/AA/Veteran/Disability Employer. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.