1.Performing literature search and preparation of clinical overview for EU and /or Emerging /other countries.
2. Timely Preparation and review of PV agreements (PV masteragreements & PMP/SDEA etc.), smPC, PIL, PI, PSMF and RMP as per applicablecurrent regulatory guidelines of US/EU and or Emerging countries as per thecurrent required regulatory guidelines.
3. Preparation of the responses for the assessment report receivedfrom the Regulatory Authorities after the filling of a dossier for a medicinalproduct, within the specified time period.
4. collection and tracking of the adverse events as well as othercomplaints through different sources.
5. Performthe triaging of received individual case safety reports through different sources(literatures, spontaneous and regulatory authority reports.)
6.Reporting of ICSRs to applicable regulatory authority within time frame.
7.Responsible for management and timely submission of individual case reports aswell as aggregate report in order to achieve 100% regulatory compliance.
8. Periodicreconciliation of adverse events/markets complaints, if any with Emcure affiliates/Partners, pharmacovigilance service providers and distributors/ marketing partners in Indiaand emerging markets.
9. Medicalassessment and review of adverse events of seriousness, causality and expectednessfor products marketed in EU, US, ROW region, for completeness and regulatory complianceand electronic submission of ICSRs to USFDA.
10.Co-ordination and timely follow up with internal QA/QC department for QA/QCdepartment for product complaints and Regulatory teams (US, EU & Emerging)for safety exchange information for timely closure of the concerned queries.
11.Providing support as needed for regulatory authority inspections and conduct trainingfor new employees.
12.Performing signal detection and management activities for company products aswell as contribute in performing benefits risk analysis of the product whenneeded.
13.Contributing to the ongoing enhancement of Pharmacovigilance processes andpreparing standard operating procedures related to pharmacovigilance, asneeded.
14.Supports line manager to escalate any safety related issues if it is identified.
15. Performquality review of the adverse event case reports in safety database whennecessary.
16. PerformMedical review of the adverse event case reports in safety database.