Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
Perform triage of cases and determine seriousness and relatedness across products as assigned
Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.
Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
Conduct assessment of litigation cases across products as assigned
Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
Perform any other drug safety related activities as assigned.
Skills required
Excellent Attention to Detail
Proven experience in customer handling and relationship.
Proven ability to perform task management.
Proven people management skills.
Very strong written and verbal communication skills, including excellent presentation skills
Relevant product and industry knowledge
Ability to think laterally
Fluency in English (written and spoken)
Strong computer literacy (MS Office)
Job Posted by
Synowledge
At Synowledge, our mission is to help our clients improve patients quality of life though cutting-edge technology solutions and innovative consulting services. With nearly 10 years experience, Synowledge has become a strategic partner with many Top 20 Pharma and Fortune 500 companies. Our technology solutions and innovative consulting services help life sciences companies reduce cost, accelerate growth and minimize time to market during the drug development lifecycle.
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