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Manager, Safety Evaluation & Risk Management

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 five 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 2022.

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 Manager, Safety Evaluation & Risk Management (SERM). The Manager, SERM provides safety scientist support for the medical and scientific functions for safety evaluations for assigned products. Such tasks include standard safety surveillance, signal detection and signal evaluation activities. Also serves as the lead author and project manager for aggregate safety reports.

CORE ACCOUNTABILITIES:

The successful candidate must be able to perform each of the following satisfactorily:

  • Provide scientific support to safety activities for the Intercept Safety Physicians, as appropriate, based on data from clinical trials and post-marketing experiences.
  • Serve as lead author and project manager to lead the preparation of aggregate safety reports required by health authorities such as: Development Safety Update Reports (DSUR), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSUR/PBRER), US Periodic Adverse Drug Experience Report (PADER), etc.
  • Conduct clinical trial and post-marketing safety surveillance and safety monitoring activities.
  • Conduct the evaluation of safety signals according to standard operating procedures (SOPs), work instructions (WIs), and guidelines. Formulate data analysis strategy and author safety analyses reports with alignment of Safety Physicians.
  • Ensure that safety issues are documented and communicated to the appropriate stakeholders in a timely fashion.
  • Coordinate and lead cross functional meeting to support development of Aggregate Reports.
  • Participate in safety governance committee meetings, as needed.


Additional responsibilities and skills include:

  • Accountable for signal detection and signal evaluation activities including:
    • Ongoing review of sources of potential safety information.
    • Standardized literature safety surveillance.
    • Escalates safety observations, as appropriate, for possible signal detection.
    • Requests data from various stakeholders as needed (e.g. exposure data from commercial, clinical trial data from biostats, post-marketing data from PV Operations, epidemiology data)
    • Authors/contributes to Signal Evaluation Reports.
    • Maintains the Safety Signal Tracker (SST).
  • Ensure documentation of Safety Review Committee actions and recommendations
  • Contribute to aggregate safety analysis and case level review in accordance with the established strategy.
  • Ensure regulatory and pharmacovigilance commitments are met.
  • Work closely with SERM management to proactively support therapeutic area-related business.
  • Collaborate with the Clinical Development and Biostatistics teams to support the safety analysis strategy and summary of results for Clinical deliverables as needed (e.g. Clinical Study Reports, Data Monitoring Committee evaluations, and NDA submission activities.)
  • Other responsibilities as assigned.
  • 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:

  • Advanced Degree in Health or Biomedical Science (PharmD/MD/PhD.) or health-care discipline (e.g. MS, MPH, etc.) preferred. BS degree in nursing, pharmacy or other health care/life science profession required.
  • 2+ to 5 years of relevant industry experience.
  • 2+ years of pharmacovigilance experience (including experience with authoring periodic safety and signal evaluation reports).


REQUIRED KNOWLEDGE AND ABILITIES:

  • Knowledge of GVP, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
  • Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
  • Detail-oriented, with good organizational, prioritization, and time management proficiencies.
  • Must be able to work on multiple projects simultaneously. Proficient in MS word, PowerPoint, Microsoft office, excel and working knowledge of EDMS and eCTD systems.
  • Clinical/Medical writing experience including leading the authorship of periodic safety and signal evaluation reports, signal management, and risk management documents.
  • 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: Come Together, Be Yourself, Own the Solution, Embrace the Challenge, Keep Exploring.
  • Ability to have fun and thrive in a growing, diverse, and inclusive work environment



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Manager, Safety Evaluation & Risk Management

Morristown, NJ 07960
Full Time

Published on 07/26/2022

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