Director, Drug Safety & Pharmacovigilance - Safety Scientist

Department:106750 Clinical DevelopmentLocation:San Diego, USA- RemoteBe 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 Director, Drug Safety & Pharmacovigilance (DSPV) Safety Scientist will provide strategic and operational leadership for safety science activities across the company’s clinical development and commercial product portfolio. This role is responsible for leading safety signal detection and management, aggregate safety reporting, benefit-risk evaluation, safety surveillance, risk management activities, and regulatory safety responses. The Director, DSPV Safety Scientist will serve as the safety science lead for assigned products and programs, providing expert medical and scientific guidance while ensuring compliance with global pharmacovigilance regulations and company policies.Responsibilities:Provides strategic leadership for safety surveillance and safety science activities across assigned development and commercial products, including development and implementation of safety monitoring strategies aligned with regulatory requirements and business objectivesLeads ongoing benefit-risk evaluations and recommends appropriate risk mitigation strategies for assigned products, programs, or therapeutic areasRepresents DSPV on cross-functional governance committees, development teams, and strategic initiativesPerforms medical review of ICSRs from clinical trials and postmarket reports (coding, expectedness, causality, seriousness, and narratives) to ensure quality and accuracy of reportsParticipates in Medical Data Review, including coding review of clinical study dataLeads safety signal management activities of assigned products, and oversight of vendor delegated to conduct signal detection, if applicableLeads and/or contributes to the planning, preparation, writing, review and QC of aggregate safety reports (e.g. PADER, PSUR/PBRER, DSUR)Reviews and contributes to safety sections of key study documents such as Investigator Brochures, protocols, statistical analysis plans, informed consent forms, and CSRsReviews tables, figures, and listings, and safety analyses supporting regulatory submissionsEnsures ongoing assessment of risk minimization (such as REMS, RMPs, etc.) effectiveness and regulatory complianceServes as a subject matter expert during regulatory inspections, audits, and due diligence activitiesLeads inspection readiness efforts for Safety Science and safety surveillance functionsProvides strategic oversight of pharmacovigilance vendor supporting safety science activitiesCollaborates with Clinical Development, Biostatistics, Regulatory Affairs, Medical Affairs, Medical Writing, and Quality to ensure alignment on safety strategies and deliverablesMay directly manage other Pharmacovigilance personnelContributes to the development of risk management plans and product labels (e.g., USPI, EU SmPC)Leads development and continuous improvement of DSPV SOPs and/or Work InstructionsAdditional duties assigned as neededEducation/Experience Requirements: Bachelor’s degree in healthcare professional or related field required. Equitable combination of skills and relevant experience are also considered. RN, PharmD, PA or NP, or equivalent preferredMinimum 10+ years of experience in Drug Safety/Pharmacovigilance for a biotech/ pharmaceutical company in clinical and postmarketing environments8+ years of progressively increasing leadership responsibility within Safety Science or related fieldExperience leading safety surveillance, signal detection, aggregate reporting, and benefit-risk assessmentsSignificant experience authoring and/or overseeing DSURs, PSURs/PBRERs, PADERs, and RMPsStrong understanding of global pharmacovigilance regulations including FDA, EMA, ICH, MHRA, and other international requirementsStrong knowledge of MedDRA, WHO Drug Dictionary and safety databases (e.g ARGUS, ARISg, etc)Additional Skills/Experience/Requirements: The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and TeamworkDriven, intelligent, passionate about making a difference for patients with rare diseasesStrong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environmentDetail-oriented, with good organizational, prioritization, and time management proficienciesProven ability to manage multiple priorities in a fast-paced environmentStrong strategic thinking, problem-solving, and decision-making capabilitiesNephrology and/or rare disease experience preferredAbility to work effectively across global time zones when necessarySome travel (10-15%) may be required, with the potential for travel occurring over weekendsAll positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego.No role is expected to be 100% remote.Travere is an EEO/AA/Veteran/Disability EmployerTotal 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:$189,000.00 - $246,000.00*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 View email address on click.appcast.io. 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.SummaryLocation: San Diego; USA- RemoteType: Full time