- Cambridge, MA
- August 29, 2019
- Save for later
Pharmacovigilance Associate at OpenBiome
OpenBiome is the world's first stool bank—a nonprofit organization that is expanding safe access to Fecal Microbiota Transplantation (FMT) and driving groundbreaking clinical research on the human microbiome.
Since launching in 2013 out of MIT, our stool banking service has redefined the standard of care for an emerging field of medicine. When we began, only a handful of clinicians offered FMT, a treatment that has an 85% cure rate for C. difficile, the most common hospital-acquired infection in the country. Today we support FMT programs at over 1,000 medical centers across all 50 states. OpenBiome has delivered more than 50,000 treatments for recurrent C. difficile infection, radically improving the lives of thousands of patients that lack treatment alternatives.
OpenBiome has also emerged as a leading independent research organization. We have developed a pill formulation for FMT, published more than 20 scholarly works and enabled the launch of 30+ clinical trials in indications spanning autoimmune disease, infectious disease, malnutrition, metabolic disease, and obesity, and neuropsychiatric disease, to identify opportunities for microbiome-based health interventions. The research that we enable is at the vanguard of understanding how the microbes in our bodies shape major public health challenges.
The Pharmacovigilance Associate provides guidance and support for all of OpenBiome's patient and research subject safety activities.
Position Responsibilities / Duties:
Pharmacovigilance Program Management
- Project managing the expedited event processing across all functional teams to meet expedited reporting timelines
- Project managing the non-expedited event processing across all functional teams to meet appropriate timelines for ICSR completion and closeout and minimize the length of unnecessary donor hold times.
- Secondary contact for all new safety data /events received via online reporting portal
- Organizing the agenda, minutes, action items, and communication plans for Ward Rounds and Safety Management Meetings
- Surveying the landscape and help the safety team implement guidance in advance of changes
- Training OpenBiome team members across all functional groups on pharmacovigilance/safety topics as they arise and on OpenBiome’s pharmacovigilance reporting responsibilities
- Assisting with the preparation of a pharmacovigilance training packets for clinical research hires and external investigators and clinicians
- Supporting preparation and review of relevant safety materials for OpenBiome’s independent Clinical Advisory Board
- Liaising with Regulatory and Quality teams for ongoing case management, reporting requirements, and clinical safety review
- Identifying systemic process improvements in OpenBiome’s pharmacovigilance policies and procedures to ensure adherence to local and country-specific regulations and enhance patient and research subject safety
- Creating and continuing Good Clinical and Good Pharmacovigilance Practices
Pharmacovigilance Risk Management
- Attending the Material Review Board Meeting as the Pharmacovigilance representative
- Responsible for following up with Donor Operations, Safety and Project Management about outstanding safety test results
- Communicating any donor hold information to Clinical Research and Outreach to ensure any potential impact on research and enforcement material is taken into consideration promptly
Pharmacovigilance Data Management
- Liaising with Pharmacovigilance Vendors for ongoing data management across all FMT product uses (including MMS Holdings)
- Liaising with the Clinical Research and Outreach teams for relevant safety information
- Supporting the preparation, review, and storage of Safety documents, including Clinical Study Reports, Investigator Brochures, Drug Safety Update Reports, Periodic Benefit Risk Evaluation Reports, Risk Management Plans, Clinical Overviews, Summary of Clinical Efficacy and Summary of Clinical Safety
- Assisting with preparation of responses to regulatory agency action letters and other requests
- Conducting ongoing review and accuracy of Tables, Figures, and Listings (TFLs) and other safety data
- Collaborating with Regulatory Affairs Associate any potential impact on BBMFs or INDs
Skills, Knowledge, Qualifications, and Experience:
- The Pharmacovigilance Associate requires a BA/BS degree or higher and at least 2-3+ years of experience in pharmacovigilance, regulatory, or a related field regulated by the FDA
- Very strong writing and editing skills
- Strong knowledge of drug development and clinical trials
- Very strong proficiency in regulatory (FDA, ICH, GCP, and GMP) guidelines
- Experience with international pharmacovigilance guidelines is preferred
- Ability to multi-task and manage multiple deadlines simultaneously
- Highly detail-oriented and organized
- Open to receiving both formal and informal feedback
- Passion, humility, and excitement for doing whatever it takes to meet a great public health need
- Must be legally eligible for work in the United States
OpenBiome is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, status as a qualified individual with disability, or any other legally protected status. All applicants must be able to show proof of eligibility to work in the United States.