Kaustubh Vijay Kandharkar sm Fausto Jandharkar@gmalleom () 917972721528 Unkedin comyinykaustbl-andhackar SUMMARY "Experienced in Life science and Pharmacovigilance field, Seeks an appropriate position for working with an organization having a strong vision and mission to enhance its grovith and development providing simultaneous opportunities for serengthnening the foundation of my own self further enhance my knowledge. EXPERIENCE Senior Medical Safety Officer Eversana [November 2021 - April 2023, Pune, Maharashtra, India Provided dedicated support on Medical Information/Drug Safety aspects of the clinical trial process and collaborated with other functional areas ofthe organisation, Maintains, understanding and compliance with SOPs, Work instructions (Ws), global ddrugfbiologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process. Resolved preventable issues with drug safety database by working with IT Department, which decreased the audit time by 40% Reduced safety profile writing time by 33% by standardising the process. Collaborated with international affiliates to ensure accuracy and completion of drug safety reports Developed and maintained safety-related documents fr regulatory submissions stablished continuous processes and procedures to ensure compliance with applicable regulations and clfent standards Successfully analysed ané reported on safety data for adverse event trends and safety signals. Senior Drug Safety Specialist Fidelity Health Services August 2020 - November 2021, Mumbai Handled processing of individual case safety reports (ICSR) receipt via data exchange system, spontaneously as well as from business partners ‘Responsible for case validation to check whether minimum valid criteria meet to initiate Complete End to End Processing ofthe case. Review of adverse events case reports of regulatory reporting, Senior Drug Safety Associate Bioclinica January 2020 - August 2020, Mysuru, Karnataka ‘Sled in health eare information entry into PVD quality and tracking systems for receipt and tracking ICSR. Assisted in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans. ‘Triaged ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Data Bntry into safety database. Coding events, medical history, concomitant medications and test. Data analyst Cognizant Technology and Solutions June 2018 - November 2019, Pune, Maharashtra, India ‘riaging and prioritizing cases based on seriousness criteria and coding of products using Company Dictionary and WHO DD and assessing and categorizing the Quality complaint cases. Following client specific regulations and Duplicate searching of cass. Enter information into PVG quality and tracking systems for receipt and tracking ICSR Assisting in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans. Drug Safety Associate Tata Consultancy Services May 2015 - November 2018, Pune, Maharashtra, India Processed individual case safety reports (ICSR) receipt via data exchange system, spontaneously aswell as from business partners. Handled case validation to check whether minimum vali criteria meet to initiate. End ta End Processing ofthe case. Review of adverse events case teports of regulatory reporting. Coding of medical terminology in (MedD&A) ofall adverse events, indications, medical history and medic cases based on the stipulated four minlmum criteria. Responsible for delivering all operational services productivity levels ofthe team, ns and assessing the the SLA and maintaining the quality and EDUCATION M.PHARMACY Pune University + 539% Pune » 20xB.PHARMACY SARCLMU. Nanded University » 639% « Nanded - 2012 CERTIFICATIONS Pharmacovigilance Aggregate Reporting Udemy + 2023 Itcoversall aspects of Aggregate Reporting of cases in Pharmacovigilance Certificate course in clinical research Udemy «2023 Signal detection and Management in Pharmacovigilance ‘Udemy - 2023 SKILLS + Well-versed with Argus 7.0.5 safety database. MedDRA. + Strong computer skills including, creation of templates, and working with safety databases applications. * Manual testing of database and apps identifying bugs and errors in that to make them user friendly + Sense of urgency and commitment for timely completion of activities, + Safety Database systems and knowledge of medical terminology required * Good understanding of clinical tril process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance + Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other ‘management/shared content/workspace) and internet. + Ability to work independently and ina team environment + Practical hands-on using Oracle Argus (Core) Aris G, and Trilogy Health Safety database + Good communication and interpersonal skills, bth written and spoken + Good organizational skills with proven ability to prioritize and work on multiple tasks and projects “Detail oriented witha high degree of accuracy and ability to meet deadlines. + Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative Ieadership ability. + Self- motivation and proactive stance to work. Sound knowledge of regulatory guidelines related to PV domain. * Narrative Writing. -MeDRA Coding, Sound knowledge of Pharmacological concepts ‘Command on Verbal and Written communication skills “team player