Job Description

Department:

107500 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 Executive Director, Pharmacovigilance reports directly to the VP, Pharmacovigilance with responsibility for the implementation, execution, and management of pharmacovigilance and risk management activities in compliance with global regulations and consistent with industry standards.

This role will lead operational aspects of pharmacovigilance for investigational and marketed products, providing oversight to our vendors to ensure timely report processing and submission as well as ongoing signal detection and risk-benefit activities.

Essential Functions:

• Support development of the global pharmacovigilance strategy to ensure compliance while aligning with corporate clinical development and commercial goals.
• Direct the execution of pharmacovigilance activities and processes for products in clinical development and marketed products, with primary responsibility for the oversight of pharmacovigilance vendors.
• Oversee signal detection and risk management activities for all products in clinical development and implement appropriate risk mitigation strategies to ensure patient safety.
• Provide strategic planning and pharmacovigilance input to support product regulatory submissions (IND, NDA, and product labeling).
• Participate in oversight of patient safety in clinical development clinical trials, including support for study teams by providing safety input to protocols, ICFs, CRFs, as well as DMC activities as required.
• Provide pharmacovigilance expertise to process development and redesign, including oversight of pharmacovigilance training.
• Serve as pharmacovigilance expert in responding to and resolving safety questions received from or requested by regulatory authorities or ethics committees.
• Contribute to all forms of pharmacovigilance governance, including committee meetings and management of communication of product risk-benefit profile to internal and external stakeholders.
• Lead the pharmacovigilance support for any regulatory inspections.
• Actively participate and serve as pharmacovigilance representative in senior leadership committees.

Education/Experience Requirements:

• Bachelor's degree in a scientific discipline required; Higher degree or MD strongly preferred. Equivalent combination of education and applicable job experience may be considered.
• 12-15 years' experience in Life Sciences and/or Pharmaceutical industry, including at least 8 years' experience in global pharmacovigilance and drug safety.
• 6-8 years' demonstrated leadership experience managing internal teams and external partners.

Additional Skills/Experience/Requirements:

• Expertise in global safety regulations - FDA, EU GVP, ICH guidelines, and other applicable global safety regulations and guidance.
• Expertise in clinical safety assessments, signal detection and risk management, including interactions with regulatory authorities.
• Experience in pharmacovigilance inspections.
• Experience and knowledge in IND and NDA submissions.
• A leader who inspires trust and confidence in others.
• Demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
• Effective and constructive communication skills, experience in coordinating across all levels in a matrix organization, including senior management.
• Strategic assessment and evaluation skills with strong decision-making abilities.
• Ability to navigate fast-paced and dynamic work environment with expertise in collaborating with various functional groups.

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:

$235,000.00 - $315,000.00

*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.

If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. 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.

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer

 

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