Shailesh Bhosale

About Shailesh Bhosale

I am a Pharm.D. postgraduate (Doctor of Pharmacy) with 10 years of experience in PV, medical writing, and quality review. In my current role as Deputy Manager – Pharmacovigilance & Medical Services, I play a pivotal role in ensuring regulatory compliance, patient safety, and the effective oversight of pharmaceutical products. I manage the pharmacovigilance system and lead a dedicated team, ensuring that all safety-related processes are aligned with both global and local regulations. Additionally, I am responsible for overseeing Bioequivalence/Bioavailability (BA/BE) studies, collaborating closely with Contract Research Organizations (CROs) and external consultants to ensure that studies are executed efficiently from start to finish. As the Qualified Person for Pharmacovigilance (QPPV), I ensure full compliance with regulatory standards and prepare monthly reconciliation safety reports for various clients.In addition to my core responsibilities, I also prepare and implement Safety Data Exchange Agreements (SDEAs), which ensure that safety data is shared in compliance with regulatory requirements.I am responsible for ensuring all regulatory documents, such as Patient Information Leaflets (PILs), Summary of Product Characteristics (SmPCs), Material Safety Data Sheets (MSDSs), and bio-exemption reports, are available and accurate for domestic, ROW, and Stringent Regulatory Authority (SRA) markets. I coordinate responses to regulatory queries and ensure smooth dossier submissions.In addition to my regulatory responsibilities, I have extensive experience in medical writing and quality review. I began my career in medical writing, progressing to a role as a quality reviewer. I am highly skilled in performing consistency checks between subject and source documents, ensuring factual accuracy, completeness of information, and identifying any discrepancies or errors. I have reviewed a wide range of regulatory documents, including CSRs, ICFs, clinical protocols, RMPs, ICSRs, CERs, CEPs, Safety and Clinical SSCPs, PMCFs, Post-Market Surveillance (PMS) reports, and Periodic Safety Update Reports (PSURs).Additionally, I possess hands-on experience with databases such as EudraVigilance, the ADIS Insights/Reactions Weekly database, and Argus, and am proficient in ICSR case processing, causality assessment, MedDRA coding, and regulatory submission processes

Experience

1. Senior Manager

   ADVANZ PHARMA

   Mar 2026 — Present · Mumbai, IN

Education

• Bharati Vidyapeeth

  Doctor of Pharmacy (PharmD), Clinical Pharmacy