Senior Drug Safety and Pharmacovigilance Specialist

About the role

The Senior Drug Safety and Pharmacovigilance Specialist will be responsible for monitoring the safety of pharmaceutical products, both approved and in development. This position will support the PV team in ensuring flawless execution of PV operations, implementing safety reporting processes, and ensuring compliance with FDA and global safety reporting requirements.

Primary Job Functions

• Management of Travere’s drug safety mailboxes, including archiving emails and documents
• Aid in the review of individual case safety reports (ICSRs) for accuracy and quality
• Track ICSRs from clinical studies and postmarket cases and ensure timely submission to applicable regulatory authorities and business partners, including distribution to IRBs/Ethics Committees for cases meeting expedited safety reporting.
• Aid with AE/SAE reconciliation activities with 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
• Cook with vendors to ensure all internal and external timelines are met, potential issues are communicated, and resolution is achieved in a timely manner
• Create and maintain study-specific Safety Management Plans (SMP) and the study-specific configuration of the safety database
• Coordinate with vendors to ensure all internal and external timelines are met, potential issues are communicated, and resolution is achieved in a timely manner
• Develop safety report forms for both clinical trials and postmarket, such as study-specific safety report forms and pregnancy report forms, and postmarket AE report forms
• Participate in Study-Management Team (SMT) meetings as required and escalate any issues with AE management
• Aid in the development and implementation of PV-related guidelines, work instructions, SOPs, and ensure the uniform and timely processing of adverse event data
• Support the development and implementation of PV-related guidelines, work instructions, SOPs, and ensure the 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 (WIs), global regulations (such as FDA and EU Directives), GxPs, and ICH guidelines
• Other responsibilities as assigned

Essential Qualifications and Skills

• Bachelor’s degree in a related Life Sciences discipline (RN, PharmD, PA is 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 MedDRA dictionary relevant to AE/SAE coding.
• Proficiency using Safety databases (e.g. Argus, ARISg) and knowledge of Clinical trial databases (e.g. Medidata Rave, etc).
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
• Self-motivated, well-organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
• Able to work both independently and in a team environment.
• The ideal candidate will embody Travere’s core values: Patient-Inspired, Courageous, Promote Community, and Stronger Together.

Other Requirements

• 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, with a potential travel occurring over weekends

Total Rewards Offerings

Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization. Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off. Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees. Target Base Pay Range: $95,000.00 - $124,000.00 This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location.