Jul 2023 – Jan 2025 · 1 yr 6 mos

• Performed Quality check of all the Individual Case Safety Reports (ICSR) into the safety database.
• Performed literature screening and review from Pubmed, country specific journals and journals of company specific TA.
• Co-ordinated with medical reviewers of potential safety issues and assisted them in monitoring safety profile of product appropriately.
• Generated various line listing of Argus fields and tracked them for corrections.
• Assessed adverse events for labelling (global including USPI labelling), seriousness, causality and expectedness whenever needed.
• Performed case deletion activities.
• Accessed the designated mailbox monitoring as per client procedure.
• Assisted in reconciliation of mailbox activities (for various vendors) as needed.
• Assisted in performing various listings related to ARGUS fields.
• Assisted in taking daily feedback sessions and prepared MOM as and when required.
• Assisted in team bonding and team management activities.
• Participated in audits and inspections when required.
• Trained and mentored new associates.
• Tracked, monitored and assigned cases as per regulatory timeline.
• Prepared and produced quality and quantity data of associates.

May 2021 – Oct 2022 · 1 yr 5 mos

• Performed data entry of Individual Case Safety Reports (ICSR) into the safety database in timely manner
• Reviewed and evaluated adverse events (AE) case information to determine required action following internal policies and procedures
• Entered and coded, as applicable, case data, including, but not limited to event, seriousness, reported causality, medical history, drugs, procedures, indications, and laboratory data according to MedDRA, WHO-DD dictionaries
• Followed up with sites regarding outstanding queries, reconciliation of discrepancies and departmental AE workflow procedures
• Performed closure and deletion of case requests and any other drug safety related activities as assigned
• Scheduled and attended daily quality feedback meetings and provided necessary fdbacks to new associates
• Worked on distribution of cases to various authorities.

Mar 2019 – May 2021 · 2 yrs 2 mos · Thane, Maharashtra, India · On-site

• Assisted with reconciliation, case closure, translations, and ensured reports are sent within assigned deadlines
• Mentored new associates and provided oversight on operational activities and sound understanding of project protocol, therapeutic indications, and scope of work (SOW) for assigned projects
• Participated in team meetings and provided regular feedbacks to operations team manager and lifecycle safety management (LSM) on operational project metrics, out of scope work challenges/issues and successes
• Worked with LSM constructively in a matrix framework to achieve project and customer deliverables
• Scheduled weekly quality meetings and shared minutes of meeting with the team
• Assisted manager in various ad-hoc activities such as providing team productivity, team quality and e-training compliance report.
• The work profile includes hyper-linking, Bookmarking and publishing the regulatory reports using eCTDXPress, ISI Publisher and ISI Toolbox.
• Processing of documents using eCTD Xpress, ISI Publisher, IMMS (Documentum), Lorenz, Viewpoint tools.
• Perform Submission publishing activities for the different regions with applicable dossier formats. Support regulatory submissions publishing MRP, DCP, CP and National filing.
• Handing submission in EU Market, variation (CP- Initial, Response and closing sequence) Marketing Authorization Application, DMF, Annual reports, Investigator updates, Ad-promotional materials (single, multiple child), CMC, Labelling supplement, DSUR (updates to cover labeling, stability and CMC changes) submissions.
• Responsible for the building, publishing, reviewing, archiving and submitting the high-quality regulatory submissions to regulatory agencies within given timelines and in accordance with regulatory guidelines.
• Ensure the use of appropriate document management, Publishing and Validation tools through use of working practices and quality control steps to ensure regulatory compliance.

Apr 2016 – Mar 2019 · 2 yrs 11 mos

• Achieved quarterly review performance of 100% productivity and 98% quality in ICSR processing
• Verified the accuracy, completeness, and validity of +10 AE reports each day as per work instructions and coding manual
• Ensured seriousness of safety reports in compliance with company core data sheet and Important Medical Event (IME) list to avoid regulatory noncompliance
• Performed timely query responses on missing elements of safety records to ensure validation before archival in the safety database
• Mentored (6) new associates in ICSR processing to help increase the team’s productivity by 25% in a month
• Minimized late submissions of safety reports by 75% by performing root cause analysis and conducting training sessions
• Reconciled interventional study reports every week to ensure consistency with the client database
• Performed reconciliation and nullification of ICSR reports as per guidelines.