Aggregate Report Manager

1. Analyzes, reviews, and interprets safety data, both non-clinical and clinical and any other relevant sources
2. Authoring and review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities`
3. Performing literature search and presentation of relevant articles for the aggregate reports.
4. Management and reconciliation of relevant process trackers
5. Subject matter expert (SME) along with training and mentoring ofindividuals
6. Generation of Periodic Safety Line Listings (PSLL) from safety database
7. Exposure in handling regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries.
8. Providing reliable support for high priority Ad-hocactivities
9. i. Interacting withappropriate clientpersonnel to resolve issues related to the Aggregate reports as per clients policies
10. Ensuring that deliverables to the clientscomply withthe relevant regulatory requirements and are sent to the client within agreed timelines
11. Contributes to safety and pharmacovigilance trainingprograms
12. Collaborates with Regulatory Affairs to ensureappropriate reportingof pharmacovigilance and drug safety information to regulatory agencies and prescriber community
13. Training and mentoring of Pharmacovigilanceassociates

EDUCATION AND EXPERIENCE REQUIRED:

1. Minimum 7 years of experience in authoring and reviewing along with team management of medical writers
2. Degree in Life Science/Pharma or Equivalent