Aggregate Report Specialist

About the role

Authoring and review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR, health authority responses) for submission to local and other Health Authorities` Performing literature search and presentation of relevant articles for the aggregate reports. Management and reconciliation of relevant process trackers

What you'll do

• Performing literature search and presentation of relevant articles for the aggregate reports
• Providing reliable support for high priority Ad-hoc activities
• Interacting with appropriate client personnel to resolve issues related to the Aggregate reports as per clients’ policies
• Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines
• Attend internal and technical team meetings as required

What you need

• 1–3 yrs of experience
• Pharmacovigilance
• Clinical research
• Regulatory affairs
• SOP writing
• Reconciliation
• Any graduate

Good to have

• Documentation
• PowerPoint