Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Global Medical Safety (GMS) PharmD Fellow in Horsham, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Global Medical Safety is dedicated to protecting patients. The department serves as a strategic asset by championing excellence in safety science and risk management and delivering scientific value throughout a product’s lifecycle. As part of Janssen Research & Development, we are a global organization and are represented by working facilities in Horsham, Pennsylvania, USA; Spring House, Pennsylvania, USA; Titusville, New Jersey, USA; Raritan, New Jersey, USA; Toronto, Canada; Shanghai, China; Tokyo, Japan; Beerse, Belgium; High Wycombe, United Kingdom; and other safety offices throughout the world.
This one-year Fellowship within the Pharmacovigilance Evaluation and Reporting group is a postgraduate training program designed to prepare the Fellow to become proficient at aggregate safety analyses and aggregate report writing. He/she will contribute or will be responsible for report writing and/or report ownership related to core safety deliverables including scheduled and ad hoc post-marketing aggregate reports. The Fellow will be exposed to case processing, safety surveillance, and review of medical literature and clinical trial data. Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents. The Fellow will partner with team members, stakeholders, and a vendor and will have the opportunity to work on products from different therapeutic areas.
• Evaluate adverse events and other safety concerns for marketed drugs throughout a product’s lifecycle
• Review adverse drug events, epidemiological studies, single case reports, and literature
• Apply medical insight and drug knowledge in single case assessment for possible drug associations
• Respond to requests of health authorities globally through preparation of Ad Hoc Reports and other documents addressing specific safety issues and supporting labeling changes and updates
• Prepare aggregate regulatory reports, such as Periodic Benefit Risk Evaluation Report and Addendum to Clinical Overview
• Develop an understanding of the overall post-marketing drug safety process, including safety surveillance and signal detection
• Improve verbal communication skills through professional presentations and team meetings
• Interact with members in regulatory, clinical, and surveillance functional groups along with other pharmacists and fellows across the Janssen Pharmaceutical Companies network.
Please visit http://www.jnjpharmarnd.com/ for more information.
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