Associate Director, Pharmacovigilance Operations & Compliance

Department:

Location:

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 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 Associate Director Pharmacovigilance Operations & Compliance will be involved with pre- and post-marketing drug safety and pharmacovigilance activities. This role will be responsible for the oversight of case processing activities and lead the management and oversight of PV service provider ensuring timely submission of safety reports in compliance with SOPs guidelines and worldwide pharmacovigilance regulations and developing relevant key performance indicators for compliance monitoring. This role will lead PV inspection readiness activities and will work cross-functionally at all levels in the organization as well as with multiple external vendors.

Primary Job Functions

• Lead the oversight of day-to-day operations activities with the PV service provider including the development and/or maintenance of procedural documents related to safety processes

• Adherence to global regulatory regulations and reporting timelines for all expedited safety reports

• Lead the development and maintenance of KPIs compliance monitoring and quality reviews

• Develop Quality Review program for safety case reports and other safety documents

• Perform quality check of individual case safety reports safety forms and or other safety documents

• Oversight and/or perform safety activities associated with case management such as SAE reconciliations vendor reconciliations and submission compliance

• Oversight of safety activities involving business partners to ensure compliance with contracts PV agreements or Safety Data Exchange Agreements

• Lead PV inspection readiness activities and manage a state of always ready for inspection

• Active involvement in regulatory inspections and audits involving pharmacovigilance

• Ensure compliance-related investigations and development and implementation of corrective and preventive action (CAPA) measures on deviations/quality events related to pharmacovigilance

• Oversee the development and maintenance of safety-related plans including safety management plans vendor oversight plan and SAE reconciliation plans

• Lead and/or maintain PV department project management activities (e.g. organize safety team meetings maintain safety project timelines take meeting minutes archive safety-related documents etc).

• Support the authoring or review of aggregate safety reports such as the Periodic Safety Reports (PBRER PADER) DSUR periodic line listings ad-hoc analyses etc. as assigned.

• Support vendor audits and inspections

• Support signal detection and risk management activities

• Support authoring of PV SOPs and/or Work Instructions and PV related training materials; and maintains departmental and pharmacovigilance documentation in an audit/inspection-ready state

• Other responsibilities as assigned

Essential Qualifications and Skills

• Minimum 8 years of pharmacovigilance experience in pharmaceutical/biotech industry or CRO company with at least 4 years hands-on experience in adverse event case management is required

• Vendor oversight and safety case processing experience is required

• Bachelors or higher in health/biomedical science healthcare-related degree preferred (e.g. RN PharmD PA etc)

• In-depth knowledge of FDA EU ICH guidelines global PV regulations and other global regulatory requirements for clinical and post-marketing safety

• Proficient in using MedDRA dictionary and safety systems (e.g ARGUS ARISg etc)

• Experience with audits and inspections preferred

• Strong interpersonal and communication skills; proactive approach

• Able to work independently and in a team environment

• Detail-oriented with good organizational prioritization and time management skills

• Must be able to work on multiple projects simultaneously

• Demonstrated problem-solving skills (including taking ownership to ensure timely resolution) a strong sense of urgency keen attention to detail and the ability to successfully execute in an environment under time and resource pressures.

• Proficient in standard computer software (Word Excel and PowerPoint).

Other Requirements

• Office and home office environment.

• Some travel (10%) may be required with a potential of travel occurring over weekends.

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:

*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 candidates 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 . 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.