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 marketed under the brand name \"Ocaliva®\" in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva® was the first medication to be approved for PBC in over twenty years, and sales continue to grow more than four years after its initial approval in 2016.
Intercept has also established the leading clinical development program in advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a disease that impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and the REGENERATE study of OCA remains the only Phase 3 trial to have generated positive results in the disease. A second Phase 3 trial, REVERSE, is evaluating OCA in patients with compensated cirrhosis due to NASH, with results expected in 2021.
People at Intercept are passionate about patients. You'll see their photos lining our walls and hear their stories in town halls. We're equally passionate about our team and ensuring each member reaches their potential. We brave new challenges together. That's how we find better ways to get things done and break down barriers. It's also how we make it fun to work here.
At Intercept, we foster an environment that celebrates creativity, collaboration and mutual respect. We never hesitate to lean on our teammates and work together. Our relatively small size means you partner with accessible leaders who know you by name. This brings accountability and growth, which all add up to more opportunities to learn something new every day. A strong commitment to diversity, equity and inclusion is engrained in both our culture and our business. For self-motivated leaders who are ready to make a difference in the lives of patients, Intercept is a great place to be.
As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking a Senior Manager, Compliance, Training, Quality and KPIs.
The role is responsible for developing, performing, enhancing, and training for compliance and quality systems and strategies for the Medical Safety & Pharmacovigilance (MSPV) Department and contract service providers (CSPs) supporting MSPV or PV-impacting activities. This person serves as the MSPV Training Coordinator, facilitates MSPV documentation of standard operating procedures (SOPs), facilitates departmental QEs and CAPAs, and maintains key performance indicators for monitoring safety reporting, procedural and compliance performance metrics, vendor management, PV agreements management, pharmacovigilance training, and maintenance of standard operating procedures. The individual will perform departmental compliance and quality assurance activities related to pre- and post-marketing domestic and foreign country regulations and guidelines specifically to support the MSPV Leadership in promoting a worldwide business culture that accepts regulatory compliance as an expectation, with continuous process improvement as an outcome and goal.
The successful candidate must be able to perform each of the following satisfactorily:
- Lead the MSPV intradepartmental and MSPV impacting cross-functional Compliance activities:
- Supports and documents compliance with PV agreements by partners and contract service providers (CSPs), PV CSPs can include database providers, CROs, contractors, and other vendors as identified.
- Manages and supports the data quality review process; performs retrospective quality review, generates quality metrics and independently identifies and/or supports in identifying trends. Works within the department and with MSPV CSPs to improve and maintain data quality, and provide recommendations to the MSPV team and MSPV CSPs on improvement measures based on quality review results.
- Oversight of all Pharmacovigilance regulatory submissions in conjunction with the regulatory team. Performs reviews and determines regulatory submission compliance. Ensure timelines and quality of regulatory reporting.
- Administer, collect, and regularly report key performance indicators (KPIs) related to MSPV activities.
- Review and track KPIs for cases and aggregate reports for quality assurance and quality control compliance and measures.
- PV CSP oversight support, including KPI metrics generation and review, contract compliance, quality and timeliness of deliverables and continuous improvement.
- Conducts and reports on periodic testing of the PV System per SOPs, including but not limited to, testing for QPPV access, Business Continuity Plan, etc.
- Conduct periodic reviews of MSPV SOPs to identify KPIs and work with functional area heads to confirm measurements and reporting of measurements.
- Provide functional support to maintain the PVA Tracker, including KPI documentation needs.
- Support the pharmacovigilance (PV) Quality System including:
- Lead assigned MSPV management of QE/CAPA initiatives.
- Assist and facilitate QE/CAPA documentation for MSPV team.
- Facilitation with Quality on MSPV & GXP impacting QE and CAPA investigations and documentation for MSPV QE and CAPA activities including maintenance of QE and CAPA log for MSPV inspection readiness.
- Provide support for internal audits and global regulatory inspections:
- Facilitates MSPV maintenance of inspection readiness materials
- Ensure inspection readiness of CSPs conducting PV activities through KPI metrics review, vendor audit findings, QE & CAPA generation and review.
- Collaboration with QA department to support inspection/audit activities, and maintain a state of high PV inspection readiness across all regions/countries.
- Functions as MSPV department SME for MSPV training and compliance activities.
- Lead intra-departmental and extra-departmental PV training activities:
- Act as MSPV Training Coordinator for GXP and non-GXP training activities.
- Prepare and maintain company-wide AE/PC/QPPV training materials and training documentation for new hire and annual refresher training.
- Provide initial AE/PC/QPPV training as part of new hire orientation.
- Facilitate, provide support, and document MSPV training needs, including refresher training, for business partners, CSPs, contractors, etc, including coordination of training, providing training, and documentation of training materials and training completion.
- Maintain MSPV Training Matrix including annual review with MSPV functional area heads.
- Prepare and assign training documentation per company SOPs and MSPV Training Matrix.
- Monitor MSPV training and notify management of compliance outliers.
- Facilitates documentation of additional training courses as needed.
- Provide functional support to maintain the PVA Tracker, including training documentation.
- Facilitate management of MSPV or MSPV-impacting SOPs in the electronic data management system following good documentation practices.
- Maintain oversight of MSPV SOP update schedule.
- Partner with MSPV teams and cross-functional groups, as required, in the generation, review, approval and operational implementation of governing documents, such as SOPs and Work Instructions, as necessary.
- Contribute to the development of MSPV process improvement procedures, directives or initiatives that enhance regulatory compliance and global MSPV efficiencies.
- Coordinate intradepartmental SOP gap analysis for new or revised SOPs.
- Support the PSMF (Pharmacovigilance System Master File) process to meet regulatory requirements through quality reviews of the PSMF and annexes:
- Complete quality assurance and quality compliance verifications for the PSMF and annexes.
- Act as backup PSMF Coordinator.
- Support affiliates with local PSMF obligations as needed
- Oversight of KPIs for QPPV Office contractor(s) in support of QPPV activities, PVAs, PSMF, QEs & CAPAs, etc.
- Maintain knowledge of current global pharmacovigilance regulations, updates to regulations and good pharmacovigilance practices.
- Identify need for external expertise and engage outside experts as appropriate.
- Adheres to company policies and applicable regulations including reporting of adverse events to regulatory agencies.
- 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
- BS degree in nursing, pharmacy, or other health care or life sciences related profession.
- Minimum of 8 years of experience in Drug safety/Pharmacovigilance quality and compliance in a pharmaceutical industry setting or the equivalent.
REQUIRED KNOWLEDGE AND ABILITIES:
- Ability to work independently and productively and set priorities across multiple projects with little supervision.
- Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
- Proven ability to be managed remotely and work with remote teams, leadership, service providers/business partners and matrix management.
- Expert knowledge of FDA, EMA, and other international legislation and ICH PV guidelines.
- Understanding of GxP principles and other international regulatory requirements including experience and understanding of QEs and CAPA and associated documentation.
- Experience with PSMF related systems, processes, training, and overall document maintenance.
- Experience with Safety Data Exchange Agreements and/or Pharmacovigilance Agreements and their related documentation, processes, training, and maintenance.
- Experience overseeing and managing CSPs.
- experience in direct PV audits and/or inspections involvement.
- Experience in training materials development, training presentation skills, and training documentation.
- Experience in all aspects of safety reporting from case intake and processing, through expedited and periodic reporting for spontaneous and clinical trial cases, and signal detection, risk management and communication, PV audits and inspections.
- Experience with Argus Safety database is a plus.
- Solid organizational, prioritization, and time management proficiencies.
- 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.
- Highly proficient in standard computer software (Word, Excel, Power Point).
- Proficient in Veeva, MasterControl, Visio, and SharePoint.
- Excels at building relationships and networks; influences others to achieve outcomes.
- Travel up to 10%, including international travel, may be required.
- Strong verbal and written communications skills
- Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
- Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
- Ability to have fun and thrive in a growing, diverse and inclusive work environment