Department:
106750 Clinical Development

Location:
San Diego, USA- Remote

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 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.

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:
$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.