- The Medical Reviewer is responsible for the assessment and medical review of post-marketing and/or clinical trial adverse event reports, and serving as a medical resource for the global case management team, SABR department, and other cross-functional teams as needed. This position ensures that consistent, timely, and focused medical review for safety cases is conducted according to regulatory and departmental timelines at the individual level. In addition, the medical reviewer participates in the oversight of external vendors conducting medical review.
- Completes assessment and medical review of post-marketing and/or clinical trial adverse event reports within regulatory and departmental timelines
- Ensures adequacy of recording, summarization, and handling of adverse events for marketed and developmental company products
- Assesses seriousness and expectedness for reported adverse events
- Ensures accurate coding of adverse events and serving as a resource to the medical coding staff
- Ensures due diligence in characterizing adverse events
- Authors analyses of similar events for select serious adverse reactions
- Monitors global case review activities to ensure adequate timeliness of medical review
- Liaises with program & product physicians to ensure consistency in approach to medical review as well as ensure focused oversight on critical areas related ongoing safety analyses
- Participates in the oversight of outsourced medical assessment and review activities and provides consultation for medically related questions from participating vendors
Minimum of 3 years’ experience in a drug safety surveillance setting within the pharmaceutical/biopharmaceutical industry or in a clinical setting.
Graduate of a recognized, accredited medical school.
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
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