Working on ICSR

Role: Submission of ICSRsSubmission of ICSRs to regulatory authority via electronic and/or paper format in accordance with companies-controlled documents. (e.g SOPs, WIs, Guide) and applicable regulatory guidelines. Submission/Locking of cases in safety database. Submission of PADER in electronic format to USFDA via ESG gateway. Registration of client’s product on xEVMPD. Preparation, revision, reviews of SOPs, WIs, Templates, guide and guidance training documents. Communication of urgent safety issues to line manager. Send and receive ICSR related queries to the regulatory authorities. Ensure communication with all relevant people is of a high professional standard, and that records both an internal and external communication are maintained. Ensuring compliance (Quality, Procedures, Regulations, Timeliness, Consistency) with local regulations and company’s global pharmacovigilance requirements. Deliver training to new joinee and team as per requirement. Wok with aggregate report/ ICSR team/ Medical Review team leader to escalate issues or tasks outside the normal scope of work. Support group leader for the timely submission of ICSR in order to achieve 100% regulatory compliance. Performing the quality check of RIMS database.Role: Literature ReviewReview of the worldwide scientific and medical literature in accordance with company’s-controlled documents (e.g., SOPs, WIs, Guide) relevant regulations and guidelines. Maintain permanent organized documented records of all literature safety reports received and reported. Creation of safety ID of literature cases into PvEdge database. Perform Triage activity. Perform duplicate search. ICSR- Support to be given for performing case processing including data entry, Drug coding, MedDRA coding, Listedness, assessment for expediting, narrative writing of ICSR in accordance with company’s-controlled documents (e.g. SOPs, WIs, Guide) relevant regulations and guidelines.

Role: Literature ReviewReview of the worldwide scientific and medical literature in accordance with company’s-controlled documents (e.g., SOPs, WIs, Guide) relevant regulations and guidelines. Maintain permanent organized documented records of all literature safety reports received and reported. Creation of safety ID of literature cases into PvEdge database. Perform Triage activity. Perform duplicate search. ICSR- Support to be given for performing case processing including data entry, Drug coding, MedDRA coding, Listedness, assessment for expediting, narrative writing of ICSR in accordance with company’s-controlled documents (e.g. SOPs, WIs, Guide) relevant regulations and guidelines.Role: Triage Activity Basic entry of regulatory cases received from Regulatory authority by uploading and importing files and by analyzing received source documents. Perform duplicate search. Initiating received cases in database by creating safety ids. Manage tracking of all cases received from regulatory authorities. Weekly reconciliation of regulatory cases with source of receipt.Role: Medical writingProvided manuscript drafting and publication (Original manuscripts, case reports, and review articles), data entry on Biznet. Review literature article for reference. Search and identify appropriate journals required by clients. Formatting of written articles according to journals requirement for publication. Newsletter drafting and weekly social media updates.

I have studied and deeply observed human parenteral products and their molding machines.