Associate Director, Pharmacovigilance - Safety Scientist

Department:

107500 Pharmacovigilance

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 Associate Director, Pharmacovigilance- Safety Scientist will support the Pharmacovigilance team in the medical review of individual case safety reports, support safety regulatory reporting compliance in clinical trial and post marketing, contribution to the writing and review of safety documents including regulatory safety queries and aggregate safety reports, safety review of key study documents, perform signal detection and safety assessment activities and ensure that safety signal management processes are in compliance with global health authority regulations on safety signal management practices, and support the REMS Program. This position must effectively interface cross-functionally at all levels in the organization, as well as externally with vendors.

Responsibilities:

• Performs medical review of ICSRs from clinical trials and post market reports (coding, expectedness, causality, seriousness and narratives) to ensure quality and accuracy of reports
• Participates in Medical Data Review of clinical study data
• Performs coding review of study safety data
• 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 for safety data from clinical studies
• Manages signal detection activities, including adverse event data and literature review in accordance to the SOP related to safety signal management, and oversight of vendor delegated to conduct signal detection, if applicable
• Assists and contributes to the development of risk management plans and product labels (e.g. USPI, EU SmPC)
• Supports the REMS program activities such as operational oversight for all REMS related activities, REMS vendor oversight, and development of REMS materials
• Performs medical review of product complaints and potential product quality problems and escalate if there is a need for safety quality investigations
• Assists in preparation of response to regulatory inquiries related to safety
• Prepares training materials for internal and external safety presentations (ie Investigators Meetings, SIVs)
• Supports regulatory inspections and audits, and inspection readiness activities
• Assists in authoring and/or review of PV SOPs and/or Work Instructions
• Other responsibilities as assigned by his/her supervisor

Education/Experience Requirements: 

• Advanced healthcare professional degree required (PharmD, PA or NP)

• A minimum 5+ years experience in Drug Safety/Pharmacovigilance for a biotech/ pharmaceutical company in clinical and post marketing environments

• Equivalent combination of education and applicable job experience may be considered

Additional Skills/Experience/Requirements:

• Knowledge and some experience in REMS Program Management
• Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements
• Experience with MedDRA and WHO Drug dictionary coding
• Experience with software-based drug safety systems (e.g. ARGUS, ARISg, etc.)
• 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
• Must be able to work on multiple project