Posted in General Business 30+ days ago.
Type: Full-Time
Job Description
COMPANY SUMMARY:
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.
POSITION SUMMARY:
As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking a Senior Director, Pharmacovigilance (PV) Operations to lead and contribute to the strategic direction for the Pharmacovigilance Operations function within Medical Safety and Pharmacovigilance. The Sr. Director has responsibility for global adverse event case processing, ensures processes and procedures to meet global safety reporting requirements and compliance with PV Agreements, and is responsible for management of PV systems including the global Argus Safety System and associated data outputs. This role will oversee and manage contracted research organizations handling pharmacovigilance activities on behalf of Intercept. In this position, the Sr. Director will provide strategic operational leadership to cross-functional teams as a member of the MSPV Lead Team.
CORE ACCOUNTABILITIES:
The successful candidate must be able to perform each of the following satisfactorily:
Experience and Skills
QUALIFICATIONS:
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