At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases. Intercept's lead product, obeticholic acid (OCA), is a first-in-class farnesoid X receptor (FXR) agonist. OCA, marketed under the brand name \"Ocaliva ® ,\" is approved in the U.S., EU and Canada for certain patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva ® was the first product to be approved for PBC in over twenty years and our team is proud to have been pioneers in providing the first second-line treatment option to patients with such critical need. The Ocaliva ® launch in 2016 also marked Intercept's successful transition from a development-stage company to a fully integrated commercial organization with continued growth.
In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH), which impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.
As Intercept continues to build its position as the leader in progressive non-viral liver disease and pursues its goal of bringing the first approved therapy to patients with NASH, we are seeking a Senior Associate, Clinical Safety Operations. This position will be involved with worldwide pre-marketing safety activities and will be responsible for assuring the processing and reporting of safety reports in compliance with SOP's, guidelines, and worldwide pharmacovigilance regulations. This position must effectively interface cross-functionally at all levels in the organization, as well as externally with vendors and corporate partners.
The successful candidate must be able to perform each of the following satisfactorily:
- Review and assess site reported adverse events (AEs) and other clinical trial data for potential safety issues.
- Ensure safety reports are booked in, triaged, evaluated, assessed, followed-up and closed per departmental procedures.
- Ensure the uniform and timely processing and reporting of safety reports in accordance with SOPs and worldwide regulatory authority regulations.
- Assist with the preparation of aggregate safety reports such as the Development Safety Update Report, periodic line listings, ad-hoc analyses, etc. as assigned.
- Liaise with vendors, contracted service providers, and corporate partners in order to ensure compliance with contracts and agreements related to safety case processing and reporting.
- Maintain departmental and pharmacovigilance documentation in an audit-ready state and support audits/inspections.
- Oversee outsourced activities associated with case processing such as SAE reconciliations, vendor reconciliations, submission compliance, and case QC, and case closure activities.
- Assist with the development and maintenance of PV plans including safety management plans, regulatory reporting plans, and SAE reconciliation.
- Develop and maintain department SOPs and other procedural documents.
- Other responsibilities as assigned.
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
- Drive the spirit of \"ONE Team\" across all functions by supporting a team approach to focus on our patients and customers as our top priorities
- Make Intercept a truly desired place to work
Experience and Skills
- Bachelor's degree required in a health care discipline. BSN, PharmD, PA preferred.
- At least 5 years of pharmacovigilance experience at a biotech, pharmaceutical, or CRO company.
- Safety case processing experience is required.
- Argus Safety experience is preferred
REQUIRED KNOWLEDGE AND ABILITIES:
- Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements.
- Knowledge of MedDRA dictionary relevant to AE/SAE coding
- Experience with software-based drug safety systems (ARGUS experience is preferred)
- Strong verbal, 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 projects simultaneously.