About Me
As a Pharmacovigilance specialist, I am responsible for the following task:
• Accountable for handling ICSRs.
• Acknowledging receipt of ICSR.
• Responsible for generating and forwarding appropriate queries and requests for clarification of discrepant data or additional data.
• Accurate data capture of spontaneous/clinical ICSR and Device cases
• Deletion and nullification of the cases.
• Clinical assessments which include event selections and case seriousness.
• Safety narrative writing.
• Responsible for coding medical history, events, drugs/procedures/indications, and laboratory tests according to appropriate dictionaries e.g. MedDRA, company product dictionary, WHO DD.
• Intake of ICSR, Clinical trial cases.
• Submissions of Clinical trial cases for various sites and Health authorities.
• Communication with clients, preparing invoices.
• Aggregate reporting such as PSUR, DSUR, PADER, PSMF & RMP
• Conducting and handling audits.
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$6/hr
Total Earnings
$ 0
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