Job Profile of Pharmacovigilance Officer in Pharmacovigilance Project

• Responsible for processing Adverse Event cases on the Safety database.
• Perform the duplicate case search function in software.
• Review the source document to assure relevant information pertaining to the case is appropriately entered into the database fields.
• Responsible for processing Initial/Follow-up Spontaneous, Solicited, Clinical trial Serious/Non-serious Cases.
• Event Coding by MedDRA (Medical Dictionary for Drug Regulatory Activities).
• Assessment of events with product, also case validity.
• Used CDD (Company Drug Dictionary) and WHO Dictionary for drug coding.
• Completion of remaining case data entry, including narrative writing or Auto-narrative.
• Creation of follow-up letter for required cases.
• E2B Validation of the Case.
• Follow Up activities.
• E2B Linking reports and cross reference reports
• Routing of Spontaneous/Solicited/Clinical trial cases, Serious/Non-serious cases to the appropriate workflow state.
• Responsible for performing daily activities in accordance to applicable Standard Operating Procedures (SOPs), Conventions and Client policies.
• Quality auditing for cases