Department:
107500 Drug Safety & Pharmacovigilance
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.
Position Summary:
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:
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Management of Travere’s drug safety mailboxes, including archiving emails and documents
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Assist in the review of individual case safety reports (ICSRs) for accuracy and quality
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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.
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Assist with AE/SAE reconciliation activities with all data sources, such as clinical trials, business partners, and the call center
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Maintain oversight and assist with query management, including review, approval of queries and timely closure of follow-up requests.
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Coordinate with vendors to ensure all internal and external timelines are met, potential issues are communicated, and resolution is achieved in a timely manner.
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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
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Creation and maintenance of study-specific Safety Management Plans (SMP) and the study-specific configuration of the safety database
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Participate in Study-Management Team (SMT) meetings as required and escalate any issues with AE management.
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Assist in providing vendor oversight for the processing of adverse event data in compliance with applicable global regulations and internal SOPs and SMPs
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Review Safety Report Forms and ensure consistency in the initial evaluation and assessment of the report and source documentation, as appropriate
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Support the development and implementation of PV-related guidelines, work instructions, SOPs, and ensure the uniform and timely processing of adverse event data
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Support the planning and preparation of aggregate safety reports such as Periodic Safety Reports, periodic line listings, etc., as assigned
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Support safety signal management activities, including literature search and review
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Support and participate in inspection readiness activities
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Maintain understanding and ensure compliance with pharmacovigilance SOPs, Work Instructions (WIs), global regulations (such as FDA and EU Directives), GxPs, and ICH guidelines
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Other responsibilities as assigned
Essential Qualifications and Skills:
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Bachelor’s degree in a related Life Sciences discipline (RN, PharmD, PA is preferred).
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Minimum four (4) years of relevant drug safety and pharmacovigilance experience at a biotech, pharmaceutical, or CRO) company.
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Knowledge of GVP, GCP, US and EU regulations and guidelines, and other international regulatory requirements.
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Knowledge of MedDRA dictionary relevant to AE/SAE coding.
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Proficiency using Safety databases (e.g. Argus, ARISg) and knowledge of Clinical trial databases (e.g. Medidata Rave, etc).
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Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
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Self-motivated, well-organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
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Able to work both independently and in a team environment.
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The ideal candidate will embody Travere’s core values: Patient-Inspired, Courageous, Promote Community, and Stronger Together.
Other Requirements:
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Proficient in Microsoft Office (Outlook, Word, Excel, Powerpoint)
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Ability to work effectively in both office and remote work environments
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Some travel (10%) may be required, with a potential travel occurring over weekends
Travere is an EEO/AA/Veteran/Disability Employer
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.
Travere will accept applications on an ongoing basis until a candidate is selected for the position.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [email protected]. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.
