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:
This position accepts considerable responsibility for the medical safety management of drugs in clinical development and in the post-marketing (preferred but not required) setting. The position requires strong analytical skills and the capability to effectively contribute as a strong team player.
This position will lead the ongoing signal detection monitoring, product risk-benefit assessment, and safety assessment activities of designated drugs and/or indications. The Medical Director will work closely with the Medical Safety & Pharmacovigilance team and in addition will be a key member in one or more cross functional clinical development.
ESSENTIAL FUNCTIONS:
- Serves as the Medical Safety & Pharmacovigilance Lead for designated indications or drug portfolio(s) including providing after hours coverage for urgent/emergent medical queries related to clinical study conduct and patient safety.
- Provides oversight over the monitoring of clinical trial safety and monitors site compliance with protocol-specified measures intended to ensure the safety of subjects.
- Manages compliance with standard operating procedures, regulatory, safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA) etc. for the reporting of adverse events to Regulatory Authorities
- Authors, reviews and provides input and approval for drug-safety related regulatory reports and clinical study documents including Clinical Study Protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), MedDRA coding of AEs, product package labeling, Company Core Safety Information (CCSI)
- Provides medical significance and expectedness assessment of AE/SAE reports and approving AE/SAE case narratives, compiles analysis of similar events (AOSE)and supports ad-hoc safety analyses as required by health authorities
- Represents Medical Safety & Pharmacovigilance in communications with Health and Regulatory Authorities
- Represents Medical Safety & Pharmacovigilance at independent Data Safety Monitoring Committee meetings
- Provides medical input for maintaining REMS, RMP, and post-marketing safety monitoring commitments
- Leads signal detection activities, authors signal analysis reports and provides periodic benefit-risk assessment reports. This includes the investigation and review of emerging safety data from various sources including individual clinical trial AE/SAE case reports, spontaneous Adverse Drug Reaction (ADR) reports from published literature, aggregate reports, toxicology reports, non-clinical studies, and other sources
- Contributes to the preparation of, reviews, and approves aggregate safety reports required by health authorities such as, Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), US Periodic Adverse Drug Experience Report (PADER), etc.
- Contributes to regulatory filings (including NDAs/MAAs) and responses as needed
- Develops and maintains current pharmacovigilance knowledge and ensure that team is aware of new and existing relevant procedures, guidance, and regulations
- Is an active member in internal Medical Safety & Pharmacovigilance review committee meetings
- Other duties as assigned
Required Experience:
Doctor of Medicine, US board certification or board eligibility preferred but not mandatory.
Preferred specialties include Gastroenterology, Internal Medicine
5 years minimum experience in the role of Medical Safety Physician or similar pharmacovigilance leadership role in the pharmaceutical industry
Strong skills in the management of safety information originating from both clinical development and post-marketing sources
Expert knowledge of the regulations governing pharmacovigilance and regulatory filings (including NDAs/MAAs) and responses to regulatory queries
Working knowledge of industry standard pharmacovigilance databases
Strong leadership skills and ability to communicate with individuals at all levels
Excellent oral and written communication skills
Excellent analytical skills and ability to work independently
Strong interpersonal, negotiating and team building skills
Ability to exercise creativity and judgment
LI-JN1
From: Intercept Pharmaceuticals
Source: Indeed.com
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