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About Acorda Therapeutics, Inc.:
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Restoring neurological function to people with spinal cord injury (SCI), multiple sclerosis (MS) and related conditions of the nervous system.
Click here to go to the Acorda Therapeutics, Inc. website.
For details about Acorda Therapeutics, Inc., click here.
About the Opportunity/Requirements:
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Employer Job Code: 1210
This position will be responsible for the collection, documentation and processing serious adverse events from clinical trials and all adverse events from post marketing spontaneous reports in accordance with Federal Regulations and the company’s Standard Operating Procedures.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
• Conduct complete medical review of all domestic and foreign reports for all Acorda pharmaceutical products including clinical SAE reports of investigational products received from clinical trials and spontaneous AE/SAE reports of marketed products received via call center/literature searches/etc.
• Follow case processing management of Clinical Case Reports and Spontaneous Individual Case Safety Reports (domestic and foreign reports) through case approval and closure.
• Review all medical and drug terminologies according to project specific coding conventions, Package Insert, Investigator Brochure and Company Core Data Sheet.
• Produce Clinical Safety Queries as needed for clarification of reports.
• Create and maintain workflow trackers, flow charts, Power Point slide presentations as needed.
• Serve as a Safety Liaison contact to other departments and Acorda licensing partners.
• Interact on a regular basis with Clinical Project Mgrs, Case Processing Mgrs, Medical Affairs, etc to identify process improvement strategies and communicate project status updates.
• Interact on a regular basis with contract drug safety vendor (data management, case processing, call center, etc) to resolve safety-related issues.
• Assist the Director with the creation of department SOPs, SWPs Guidance Documents, Forms
Education and/or Experience
Bachelor’s degree in nursing or pharmacy or in a health-care related field with at least 2+ years drug safety experience; working knowledge of ICH/GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG coding. Familiarity with safety databases, data entry platforms, adverse event data collection process, case processing unit, call center, product complaints, 15-day safety alerts, submissions of safety updates to the FDA, Pharmacovigilance Safety Data Exchange Agreements, Risk Evaluation and Mitigation Strategies, Medications Guides, pre-approval process and post-marketing commitments to FDA, FDA Industry Guidelines, ICH Guidelines, Regulatory Approval Process and Drug Development
Physical Demands
• No specific physical demands
Work Environment
• Ability to work in regulated environment
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