Senior Director, Pharmacovigilance Operations at Intercept Pharmaceuticals Inc. in New York, New York

Job Description:

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:

• Direct the operational management of PV Operations department and contracted vendors


• Lead organizational initiatives to drive operational excellence in PV


• Ensure compliance of the Argus Safety System in accordance with global regulatory requirements


• Serve as global Argus Safety System Governance Chair and directing and managing future upgrades, configuration changes, and issue resolution


• Provide support for Safety Signaling activities including outputs from the safety database


• Support Company Core Data Sheet and Reference Safety Information development, review, and updates


• Provide leadership and assist in the preparation or review of aggregate safety reports and other safety deliverable


• Oversee the development, implementation, and maintenance of Standard Operating Procedures, Work Instructions, Guidance, Policies, etc. for MSPV ensuring all global regulations are satisfied


• Serve as the internal Subject Matter Expert on global PV regulations and processes including expedited and periodic reports submission, notification of emerging safety information or signals, and coordinating responses to safety-related health authority requests


• Ensure compliance of PV Operations personnel and third-party vendors with corporate procedures relative to PV


• Act as the lead in internal or external audits and inspections for PV Operations


• Review and develop the continuing performance of PV personnel reporting to Sr. Director PV Operations


• Responsible for PV operational budget planning and oversight


• 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

QUALIFICATIONS:

• Health care professional degree required (RN, BSN, PA, NP, PharmD or MD), advanced degree preferred.


• 8+ years of industry knowledge experience (pharma, biotech, CRO). Experience across different sized organizations (such as both biotechnology and pharmaceutical companies) is preferable.


• 8+ years of pharmacovigilance experience, at least 5 years of postmarketing PV experience.

• Extensive knowledge of global PV/drug safety processes and regulations for clinical trials and licensed products


• Extensive knowledge and experience with Argus Safety database


• Excellent organization and multi-tasking skills.


• Exceptional interpersonal skills and problem-solving capabilities.


• Proven negotiation skills.


• Ability to work effectively across a matrixed organization.


• Ability to work independently and prioritize with minimal daily instruction.


• Ability to think strategically to improve current processes.


• 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

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