Intercept Pharmaceuticals Sr. Director, Pharmacovigilance in San Diego, California
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 potent 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 use in primary biliary cholangitis (PBC), a rare autoimmune liver disease. OCA is also being investigated as a treatment for nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).
In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to 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. By 2020, NASH is expected to overtake hepatitis C as the leading cause of liver transplants in the U.S. 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 intends to file for regulatory approval in the U.S. and EU in the second half of this year. 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 Talent Acquisition will play a pivotal role in preparing the company for the successful launch of OCA’s second indication.
This position is responsible to lead the Global Pharmacovigilance Operations activities of the Medical Safety & Pharmacovigilance Department. Drives strategic planning, roadmap and execution of the Pharmacovigilance Operations Department structure, reporting and analytics requirements from the Global Safety database and PV systems and ensures that Global PV regulatory requirements are met including the support of relevant PV Business Partners. Ensuring compliance with Global (specifically US, EU, Canada and ROW) Pharmacovigilance and Regulatory requirements for adverse event management of medicinal products, both in development and post-marketing.
Sets the direction for Pharmacovigilance Operations activities for ensuring compliance with all relevant Global PV Regulations and requirements for the processing of adverse events associated with Intercept sponsored drug products, including investigational and marketed products
Establishes the direction, standards, and processes for supporting Pharmacovigilance Operations including the strategic planning, implementation, and management of activities
Responsible for managing internal and external staff allocated to MSPV Operational activities including creating a highly efficient team across insourced and outsourced resources
Leads the PV Vendor Standards & Oversight function and directs the global oversight for management of Global Pharmacovigilance Operations Service Provider(s).
Leads innovation and strategy for the continuous enhancement of the PV Systems that are fully compliant with the applicable worldwide Health Authority PV regulations
Develops and implements an inspection readiness program in collaboration with other MSPV and non-MSPV stakeholders
Leads the interaction with relevant internal or external functions for MSPV in inspections, and audits.
Oversees and ensures the Pharmacovigilance Operations business requirements are met including establishing and monitoring key quality and compliance metrics
Responsible for a compliant and quality execution of all operational activities related to case processing including timely submissions of expedited reports to the FDA & other Health Authorities. Identifies immediately deviations and applicable corrective and preventive actions to maintain compliance at its highest level.
Contributes to, drafts and implements department SOPs, Guidelines and Work Instructions related to the MSPV activities.
Supports signal detection activities, aggregate reports, benefit-risk assessment as required
Responsible for PV vendor contracts and the oversight of PV Agreements and Safety Data Exchange Agreements with vendors, partners and others
Pharm D, RPh, RN, MD or other relevant training and education in the biomedical field with a minimum of 10 years of experience in the pharmaceutical industry and a minimum of 5 years in leadership positions in Medical Safety & Pharmacovigilance
Substantial experience in biotech/pharmaceutical industry with significant capability in product safety/pharmacovigilance for investigational and marketed products
Strong leadership and negotiation skills
Formal management training/experience and demonstrated management skills desirable
Ability to interact effectively with staff of multiple disciplines both within and outside the company both nationally and internationally required
Ability to lead/supervise activities in a high-pressure, fast paced and changing environment to ensure objectives are met in a timely manner and achieved within budget allocations required
Experience with activities associated with new product launch
Keyword: Sr. Director, Pharmacovigilance
From: Intercept Pharmaceuticals