Department:106750 Clinical Development
Location:San Diego, USA- Remote
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 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 objectives
Leads ongoing benefit-risk evaluations and recommends appropriate risk mitigation strategies for assigned products, programs, or therapeutic areas
Represents DSPV on cross-functional governance committees, development teams, and strategic initiatives
Performs medical review of ICSRs from clinical trials and postmarket reports (coding, expectedness, causality, seriousness, and narratives) to ensure quality and accuracy of reports
Participates in Medical Data Review, including coding review of clinical study data
Leads safety signal management activities of assigned products, and oversight of vendor delegated to conduct signal detection, if applicable
Leads 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 CSRs
Reviews tables, figures, and listings, and safety analyses supporting regulatory submissions
Ensures ongoing assessment of risk minimization (such as REMS, RMPs, etc.) effectiveness and regulatory compliance
Serves as a subject matter expert during regulatory inspections, audits, and due diligence activities
Leads inspection readiness efforts for Safety Science and safety surveillance functions
Provides strategic oversight of pharmacovigilance vendor supporting safety science activities
Collaborates with Clinical Development, Biostatistics, Regulatory Affairs, Medical Affairs, Medical Writing, and Quality to ensure alignment on safety strategies and deliverables
May directly manage other Pharmacovigilance personnel
Contributes 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 Instructions
Additional duties assigned as needed
Education/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 preferred
Minimum 10+ years of experience in Drug Safety/Pharmacovigilance for a biotech/ pharmaceutical company in clinical and postmarketing environments
8+ years of progressively increasing leadership responsibility within Safety Science or related field
Experience leading safety surveillance, signal detection, aggregate reporting, and benefit-risk assessments
Significant experience authoring and/or overseeing DSURs, PSURs/PBRERs, PADERs, and RMPs
Strong understanding of global pharmacovigilance regulations including FDA, EMA, ICH, MHRA, and other international requirements
Strong 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 Teamwork
Driven, intelligent, passionate about making a difference for patients with rare diseases
Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment
Detail-oriented, with good organizational, prioritization, and time management proficiencies
Proven ability to manage multiple priorities in a fast-paced environment
Strong strategic thinking, problem-solving, and decision-making capabilities
Nephrology and/or rare disease experience preferred
Ability to work effectively across global time zones when necessary
Some travel (10-15%) may be required, with the potential for travel occurring over weekends
All positions have an essential job function... For full info follow application link.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer
