Ashish Jaydeokar Email & Phone Number

Germany

Mumbai, Maharashtra, India

• Subject matter expert for reviewing aggregate reports such as RMP, PBRER, AddCo; maintaining submission trackers and ensuring compliance with applicable working instructions and SOPs.
• Supervising service providers for ICSR processing and performing final review of cases to ensure case quality of more than 95% and preventing late case submissions
• Supporting EU QPPV for maintenance of PSMF and review of safety signals
• Reviewing and updating PV SOPs at regular intervals to… Show more
• Reviewing and updating PV SOPs at regular intervals to ensure compliance with local and global PV guidelines
• Conducting periodic PV training for new joiners and sales staff. Ensuring effective communication of product safety information. Identified training and development needs and maintaining training records

Mumbai Area, India

• Led the team for setting up PV processes by drafting and implementing SOPs on various PV functional areas such as ICSR case processing, Aggregate report writing, PSMF, Signal management, Deviation and CAPA management &.
• Conducted internal audit of regional offices and trained staff members on PV operations. Provided individual feedback to the concerned staff on the processed cases and safety reports.
• Drafted PSUR (EMA GVP module VII), RMP (EMA GVP… Show more
• Drafted PSUR (EMA GVP module VII), RMP (EMA GVP module V) & AddCo. Independently authored more than 100 reports
• Conducted weekly Medical Literature Searches and preliminary triage (causality assessment, seriousness, follow up requirements and reportability) of identified hits.
• Regularly screened Health Authority websites for safety alerts and effectively communicated the safety variations with Labeling team for updating Product labels such as PI and SmPC

Mumbai

• Performed Quality review and Expedited reporting of ICSRs through Argus database to MHRA, EMA, Bfarm, USFDA and TGA. Successfully processed more than 1000 ICSRs
• Supported PSUR and RMP team by conducting ad-hoc literature search to identify safety and efficacy related publications
• Served as a point of contact with manufacturing site QA department for ICSRs involving product quality complaints

Mumbai

• Performed Data entry and Quality review of ICSRs through ArisG database
• Performed medical coding of adverse events and other medical terms through latest version of MedDRA
• Drafted PSUR according to ICH E2C guidelines and EMA GVP Module VII
• Handled medical enquiries received from consumers and provided satisfactory responses
• Provided medical inputs for updating the product labels such as SmPC and PIL

Learnt and executed succesfully various in-vitro and in-vivo ADME assays such as plasma stability, microsomal stability, CYP inhibition, protein binding, RBC partitioning, Caco-2, MDCK assays, pharmacokinetics and cannulated animal studies.

Efficiently exposed to HPLC, TLC and other quality control techniques

Bachelor Of Pharmacy - Bpharm

Master Of Pharmacy, Pharmacology