Pharmacovigilance Scientist

Company Information

Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan paediatric liver diseases and other liver or gastrointestinal diseases and disorders. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs.

Odevixibat is a potent and selective inhibitor of the ileal bile acid transporter (IBAT), sometimes also referred to as the apical sodium dependent bile acid transporter (ASBT), that has minimal systemic exposure at therapeutic doses and acts locally in the gut.

Albireo are developing odevixibat initially to treat patients with PFIC, a rare genetic liver disease, and plan to consider additional development in other paediatric cholestatic liver diseases and disorders in the future. Their Phase 3 program in PFIC includes a single randomized, double-blind, placebo-controlled, multicentre clinical trial and an open-label long-term extension study. The double-blind trial, called PEDFIC1, is underway with data read out anticipated in the Middle of 2020. (June/July).

The U.S. Food and Drug Administration (FDA) has granted to the odevixibat PFIC program or elements of it fast track, rare paediatric disease and orphan drug designations. The European Medicines Agency (EMA) has granted odevixibat orphan designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. Its Paediatric Committee has agreed to Albireo's odevixibat Pediatric Investigation Plan for PFIC. Both FDA and EMA also have granted orphan drug designation to odevixibat for the treatment of Alagille syndrome and primary biliary cholangitis. Albireo will commercialise Odevixibat in the US, Europe & Canada and will partner in remaining regions.

Job Description

Job Title:          Pharmacovigilance Scientist

Reports To:       Sr. Director of Drug Safety and Pharmacovigilance

Location:            Boston, MA

Position Summary:

A broad-based pharmacovigilance role leading safety surveillance activities and development of pharmacovigilance safety surveillance processes prior to filing for marketing approval. 

What makes this role special:

  • Seek to have a profound impact on young children and their families
  • Potentially be part of the first launch of a medicine for a rare pediatric liver disease
  • Work on a portfolio of multiple potential therapies
  • Gain a rare diversity of commercial experience
  • Develop strategy, as well as manage execution
  • Help shape the culture and future of an emerging biopharma with a big vision
  • Collaborate with a small, collegial team of good people
  • Learn from leadership with deep experience and a history of success
  • Be part of an early biopharma company in an excellent financial position
  • Enjoy great work/life balance, including flex hours, ability to work remotely on Friday’s, generous holiday schedule and business-casual work environment  

Responsibilities (may vary): This description is not intended to provide an all-inclusive listing of duties and responsibilities. Duties may change at the discretion of management, and/or management may request duties be performed that are not listed. This job description is not a contract of employment and does not change your status as an at-will employee.

Key Duties and Responsibilities:

  • Provide sponsor oversight for outsourced drug safety and pharmacovigilance activities performed by third-party vendors. Outsourced activities include:
    • Safety surveillance and signal detection activities
    • Authoring and of periodic safety reports (e.g., DSUR, PSUR, PADER)
    • Authoring and maintenance of Risk Management Plan in EU
  • Represent DSPV on clinical development teams
    • Oversee compilation of aggregate data for review
  • Participate in the buildout of the Pharmacovigilance System
    • Participate in the authoring of standard processes
    • With vendor, participate in the creation and maintenance of sections of the Pharmacovigilance System Master file
  • Participate in the development of the PV Quality System in preparation for filing for marketing approval
    • Participate in quality oversight ensuring department standards are met, including training requirements, monitoring vendor performance and implementing continuous improvement actions
    • Monitor compliance with regulations, PV agreements and internal SOPs
  • Participate in the development of the PV Quality System in preparation for filing for marketing approval
  • Participate in Data Safety Monitoring Board activities, including provision of safety information for DSMB meetings and interim reviews
  • Work with QA department to maintain a state of high PV inspection readiness across all regions/countries.
  • Participate in internal audits and global regulatory inspections including MHRA/FDA/EMA etc. as a SME for specific PV topics and processes.
  • Contribute to formal responses to inspection and audit findings related to DSPV department.
  • Manage and develop DSPV staff as appropriate
  • Assist in performing additional ad hoc activities as assigned. 

Qualifications:

Basic Qualifications:

  • Bachelor’s degree in nursing, pharmacy, or other health care-related profession or life sciences preferred or equivalent qualification/work experience.
  • Minimum of 7 years of experience in Drug Safety/Pharmacovigilance in a pharmaceutical industry setting or the equivalent.
  • Minimum of 4 years of experience working in analysis of aggregate safety data and preparation and submission of periodic aggregate safety reports
  • Minimum of 3 years of experience working with CROs, vendors and relationship management.
  • Strong analytical and problem-solving skills with superb attention to detail
  • Experience working with safety databases and systems (Aris Global preferred) 

Preferred Qualifications:

  • Global pharmacovigilance operations experience with marketed products and/or products in development.
  • Knowledge of relevant ICH, FDA, EMA, and PMDA Guidance and Regulations governing adverse event processing and reporting from clinical trials and/or post-marketing surveillance.
  • Experience with MedDRA coding and data entry.
  • Proficient with Word, Excel and Powerpoint
  • Strong verbal, written technical communication and presentation skills.
  • Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
  • Proven ability to work within a cross-functional, matrixed team with the ability to manage multiple tasks with competing timelines.

Albireo Values:
Partnership & Commitment
We believe that people and relationships ultimately determine success. We are committed to achieving excellence in everything we do. We strive to identify, attract and develop the best talent for our business, focusing on execution and teamwork.

Enjoyment & Creativity
We encourage individual creativity but believe that team effort produces the best results. We promote opportunities to contribute, providing a positive environment of curiosity and development. In the rapidly changing world of drug development, we work to anticipate changes and develop innovative approaches to meeting our goals.

Mutual Trust & Respect
We value diversity and strive to provide an inviting and inclusive environment. We seek to inspire trust and respect by taking responsibility for our actions, maintaining high ethical standards and encouraging collaboration and honest and straightforward communication.

JOIN ALBIREO

Equal Opportunity Employer

Albireo Pharma, Inc. is an equal opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

All applicants should be legally entitled to work for any employer in the U.S.

Note to employment agencies: Please do not forward any agency resumes.  Albireo is not responsible for any fees related to resumes that are unsolicited.