Aditi Temburnikar

• Planning, driving and co-ordinating the end-to-end preparation of safety documents, i.e., aggregate periodic safety data reports including Periodic Safety Update reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs) and Development Safety Update Reports (DSURs).
• Thorough understanding of styles of writing for various document types.
• Ensure comprehensive and consistent analysis of risk benefit profile of product.
• Expertise in writing clinical sections and Benefit–Risk Evaluation (BRE) sections for aggregate reports.
• Consistency review of data in the safety documents as back-up safety medical writer.
• Adhere to good documentation practice and responsible for ensuring that documents are in accordance with company’s SOPs and external guidelines.
• Area of knowledge: Excellent knowledge of the safety profiles of assigned drugs, Reference Safety Information documents, aggregate reporting conventions and guidelines, and international drug safety regulations including:.
• ICH guidelines on safety and efficacy.
• Volume 9A/New PV Legislation/GVP Modules.
• FDA guidelines.
• CIOMS Additional roles:.
• Vault Regulatory information management (RIM) and electronic trial master file (eTMF) super user.
• Mentoring new colleagues

• Introducing the new employee to the company and company's products.
• Briefing them about the trainings
• Responsible for conducting pre-boarding, on-boarding trainings and related activities.
• Work closely with different line managers for preparation of training plan of new employees
• co-odinating with the trainers for scheduling of trainings for the new employees.
• Responsible for documentation of mandatory and relevant trainings for the new employees.
• Have worked as a trainer where the primary responsibility was to train the new employee in all the mandatory Standard operating procedures and educating them to handle the data base.
• Mentoring the new employee until they are fully productive and giving timely feedback to management regarding their performance.

• Participation in inspections and audits.
• Appropriate medical interpretation and evaluation of adverse events reported from clinical trials.
• Triage, case entry, verification and coding of adverse events from clinical trials (phase 1–4) based on individual adverse event reports with an eye for quality and attention to detail.
• eTMF superuser, and involved and responsible for training and handling of queries and issues related to eTMF.
• Handled the training co-odinator activity along with case pocessing

• Handling of end-to-end case processing of ICSRs (individual case safety reports), which includes triage and case entry in the safety database (oracle Argus), followed by verification of adverse events of both serious and non-serious on the basis of individual case histories, correspondence with affiliates/sites.
• Involved in Affiliate support project which included review of ICSRs, Book-in of safety reports in company database (CCGloW) on behalf of Global Affiliates, and also in managing regular interactions based on Affiliate’s requirement.
• Handling of device cases in accordance to GXP requirements.
• Handling of drug/device combination cases, with and without the device investigation results.
• Handling of Global Safety department mailbox to ensure proper and timely communication to and from the departmental faxes and Microsoft outlook mailboxes.
• Responsible for reviewing and allocating incoming mails in the relevant mailboxes and the faxes.
• Literature surveillance:.
• Science Update via the GLIA (Global Information & Analysis) Knowledge Web / MLM (medical literature monitoring), provide Service Review, log and archive literature alerts.
• Identify and handle Safety Information qualifying for case creation.
• Import ICSRs from MLM.
• Training new colleagues on the handling of the task.
• Timely QC and review of the literature surveillance process and contributed to process improvement by identifying need for re-training the team for the task to achieve maximum QC percentage.

Total GPA 8