Pharmacovigilance Associate

Role & responsibilities

• Data Entry of ICSRs in Pharmacovigilance database. Entering source data in the database, Coding, Narrative(s) writing and Generate Follow-up letters.
• Book in and Triaging of ICSRs
• Review of literature articles and assessment for identifying valid ICSRs (if applicable)
• Quality Check of ICSRs in database (if applicable)
• Support in preparation of aggregate reports (if applicable)
• Support in Signal detection of the ADRs with cases received from client's products (if applicable)
• Compliance to project guidelines
• Execution of Company Standard Operating Procedures
• Builds and maintains good relationships across functional units and company affiliates
• Maintain awareness of changes to/new regulations affecting PVG activities
• To carry out necessary administrative duties required for the job
• Other duties as assigned by management

Preferred candidate profile