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Sr Associate II, Drug Safety - Biogen Idec
Aug 04
Location: Cambridge, MACategories: Clinical
Website: http://posttrak.arbita.net/cgi-bin/PostTrak.cgi?RefCode=R6161282206741
Position Description
The Sr. Associate I Drug Safety for Clinical Trials (also known as Safety Associate) is responsible for monitoring the company’s clinical trial drug surveillance program including the intake, evaluation, processing, and follow-up of serious adverse event reports, participation in the resolution of any legal liability and in complying with government regulations. Ensures complete and accurate maintenance and reporting of Adverse Drug Experience (ADE) data to the Food and Drug Administration (FDA) as required by Federal regulations and reporting to foreign regulatory agencies.
Essential Functions:
• Ensure compliance with corporate and departmental SOPs.
• Receipt, review, classification, and coding of clinical trial adverse event reports.
• Ensure clinical trial site staff are trained to handle serious adverse events (SAE) according to appropriate SOPs and protocols.
• Ensures the classification of all SAE and the creation, if needed, of the Analysis of Significance and Letter to Investigators.
• Collect, document, and evaluate adverse event information from Health Care Professionals using medical knowledge, experience, and communication skills.
• Generate medical narratives derived from the collection of adverse event information and verify medical coding in the safety database system.
• Generate queries for the collection of additional information for postmarketing adverse events.
• Ensure completeness, accuracy and overall individual case quality for data entered into the safety database and case documentation.
• Conduct timely internal review and processing of adverse event information in accordance with internal timeframes and timeframes dictated by regulatory authorities and safety agreements with corporate partners.
• Using the safety database system and other tracking tools, document adverse event information and case processing activities.
• Special projects as requested by management.
• Participates on SMTs (Study Management Teams)
Additional Functions:
• May assist with the review of Investigator Brochures.
• Assess adverse event information for factors that impact the understanding of reported adverse events by utilizing a clear understanding of company and their indications.
• Assist with the development of departmental procedures, as needed.
• Attend relevant continuing education courses.
• Demonstrate excellent communication skills.
• Demonstrate knowledge of applicable clinical trial regulations regulations.
• Ability to work independently on routine and new assignments.
• Ability to maintain confidentiality.
• Demonstrate strong organizational skills, including the ability to prioritize.
• Ability to work effectively in a team environment.
• Ability to understand technical, scientific, and medical information.
Qualifications
Essential:1-3 years in a clinical setting.
Preferred: 1-3 years prior experience in a drug safety unit or clinical trials unit in the pharmaceutical/biopharmaceutical industry.
Technical Skills: Proven ability to evaluate clinical data.
• Minimum of word processing skills in a Windows environment.
Interpersonal Skills:
• Excellent communication skills.
• Ability to handle multiple priorities.
• Ability to solve complex problems.
• Able to effectively communicate orally and in writing.
• Able to produce clear, concise documentation.
• Able to interact collaboratively in a team environment.
About Biogen Idec: Transforming Discovery into Care
With operations across the Americas, Europe, and Asia, Biogen Idec (NASDAQ:BIIB) is one of the world’s leading biotechnology companies, creating new standards of care in oncology, neurology, and immunology. Every day, employees of Biogen Idec make a difference in people’s lives, through pioneering research and development, manufacturing, and our worldwide commercial capabilities.
Biogen Idec is proud to be an equal opportunity employer
