Vacancy Description
Our Client, a Biotech company, is looking for a Senior Pharmacovigilance (PV) Clinical Scientist for their Remote location. Responsibilities:
+ Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and client Standard Operating Procedures (SOPs) ○ Reviews, evaluates, and verifies potential AE information during triage to determine required action per internal policies and procedures and perform data entry of adverse events by timely completion of the case via Roche global safety database. Performs seriousness / validity/causality and conducts quality review of all cases (as applicable) based on their medical assessment
+ Performs labeling assessment for AE(s) received using clinical knowledge and conducted follow up for all reported cases (as applicable)
+ Responsible for leading efforts to ensure quality of Individual Case Safety Reports (IC...
+ Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and client Standard Operating Procedures (SOPs) ○ Reviews, evaluates, and verifies potential AE information during triage to determine required action per internal policies and procedures and perform data entry of adverse events by timely completion of the case via Roche global safety database. Performs seriousness / validity/causality and conducts quality review of all cases (as applicable) based on their medical assessment
+ Performs labeling assessment for AE(s) received using clinical knowledge and conducted follow up for all reported cases (as applicable)
+ Responsible for leading efforts to ensure quality of Individual Case Safety Reports (IC...
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