Aggregate Report Specialist
MysuruFull-time1–3 yrsPosted 1 week ago
Junior pharma role at Sitero in Mysuru. Needs 1–3 years.
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
- Pharmacovigilance
- Clinical research
- Regulatory affairs
- SOP writing
- Reconciliation
Good to have
- Documentation
- PowerPoint