Job Title: EU Qualified Person for Pharmacovigilance (Consultant)
Location: Republic of Ireland
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). REGENERATE is the first and largest Phase 3 study in NASH - a chronic disease that threatens 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.
Based on the positive results from REGENERATE, Intercept submitted the first new drug application for a NASH treatment to the U.S. FDA in September 2019. This is an exciting time for Intercept, as the organization prepares for a potential approval and launch in NASH. As part of this effort, Intercept is beginning to build a new commercial organization, and this opportunity in Pharmacovigilance will play a pivotal role in preparing the company for the successful anticipated launch of OCA's second indication.
This contract Consultant position is responsible for fulfilling the role of EU Qualified Person for Pharmacovigilance for Intercept International Limited, the EU MA holder. This position will ensure corporate compliance with EU Pharmacovigilance Regulatory requirements for the pharmacovigilance system of Intercept's medicinal products approved in the EU.
The EU QPPV is responsible for
- Establishing and maintaining Intercept's Pharmacovigilance System to ensure compliance with all legal and regulatory requirements in the EU for the applicable Marketing Authorisations,
- Overseeing the safety profiles of Intercept's Marketed products in Europe, and acting as a single point of contact for EU Competent Authorities.
If the QPPV is not a physician, Intercept shall provide the QPPV with access to appropriately qualified and experienced physicians.
The successful candidate must be able to perform each of the following satisfactorily:
- Establish and maintain Intercept's PV system to ensure compliance with all legal and regulatory requirements in the EU for the applicable Marketing Authorisations
- Maintain oversight of the safety profiles and any emerging safety concerns in relation to the medicinal products for which the Intercept holds authorizations in EU
- Ensure continuous monitoring of the safety profiles of Intercept's medicinal products
- Act as the main point of contact with EU competent authorities for Pharmacovigilance
- Being available to be contacted by EMA and EU Competent Authorities 24/7
- Ensure Deputy QPPV availability during planned and unplanned absence
- Maintain oversight of the PV system both inside and outside of Europe as it pertains to the EU Marketing Authorisations
- Delegate tasks whilst maintaining final responsibility
- Oversight of
- Sources of safety information
- Individual case safety processing
- ISCR submissions
- Global Safety Database
- Standard Operating Procedures
- Periodic Safety Update Reports (PSURs),
- Risk Management Plans (RMP),
- Post Authorization Safety Study (PASS) protocols,
- Risk Minimisation Strategies,
- Effectiveness of follow-up measures,
- Post-marketing PV commitments,
- PV Quality Management System including Audits, CAPA, Quality Events, Deviations, PV Inspections
- Evaluation of safety data, signal detection / management activities, EVDAS
- Reference Safety Information, (Labelling / CCDS)
- Safety variation submission and implementation
- Contracts and agreements
- 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
- At least 10 years of PV experience gained in pharmaceutical industry, with the most recent 5 years devoted to working as a QPPV, Deputy QPPV.
- Must have strong EMA, EU national Competent Authority PV inspection experience
- If not a physician, a registered Pharmacist or science graduate.
REQUIRED KNOWLEDGE AND ABILITIES:
- Strong documentation skills
- Must have experience in oversight of
- Risk Management Plans
- PV Quality Management Systems
- Type II Variations
- Must have a strong working knowledge of European laws and regulations related to Pharmacovigilance, GPV Guidelines, ICH
- Significant experience in the pharmaceutical industry, including leadership positions in pharmacovigilance.
- Substantial capability in product safety/pharmacovigilance for marketed products
- Strong PV operational knowledge including experience with Individual Case safety report handling
- Strong leadership and negotiation skills Experience in Pharmacovigilance at EU level
- Knowledge of EU Pharmacovigilance legislation and preferably experience with data submission
- Willingness to liaise with clients for various levels of PV consultancy
- High ethical standards as well as personal credibility
- Able to work effectively and collaboratively across a virtual Global PV Team
- Has the expertise, determination and courage to resolve or escalate issues as appropriate
- 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
- Understanding the legal and compliance environment
- Ability to have fun!
This is a great opportunity to join Intercept at a pivotal time as we prepare for our next potential launch, playing a key role within the Pharmacovigilance team.