Technical query replies across pharmacovigilance systems for ROW and ANDA markets.
· Literature support for safety reporting from reputed databases such as Toxnet, EMA, UMC, Embase etc.
· Signal detection using literature search.
· Coding of Verbatim terms using MedDRA.
· Preparation and Submission of ICSR on Safety report portal of USFDA.
· Review of ICSRs and identification of errors.
· Preparation of RMP, PSUR and PBRER for ROW markets.
· Preparation of PADER for ANDA markets.
· Preparation of the related documents of aggregate reports.
· Preparation of the PSMF for ROW countries.
· Assessment of SAE validness and addressing the queries in SAE form.
· Obtain follow-up SAE information from clinical sites and Clinical Research Organizations including appropriate respond to queries on time.
· Distinguish & analyse the risks & benefits ratio for marketed products.
· Co-ordinates with all internal and external stake holders for ensuring pharmacovigilance and regulatory compliance.
· To assist preparation or update of SmPC and PIs for ROW markets.
· Prepare, review, finalization & maintain awareness and adherence to all current SOPs.
· Preparation of SDEA for ROW countries
· Provide updates for Core working practices of Pharmacovigilance activities.
· Handling queries by telephonic or email from Doctors / pharmacists / customers and giving suggestions regarding safety.
· Participate in internal and external audits, inspections and respond to audit Inspection reports in co-ordination with the QA.
Implement training programs for staff personnel with respect to GVP, SOPs in the performance of their duties