Ratul Bose

I am a dedicated and experienced Drug Safety & Pharmacovigilance Specialist with over 10 years of experience — including 7+ years in global PV operations and 3+ years of clinical practice.

I specialize in ICSR medical review, signal detection & validation, CSR and DSR drafting, and literature surveillance. I have led CAPA/RCA initiatives, mentored PV teams, and driven process improvements in coordination with clients and vendors.

Proficient in ICH-GVP, FDA/EMA guidelines, MedDRA, Argus, EVWeb, and PRAC/FDA response support. Open to global opportunities in pharmacovigilance and safety leadership.

Throughout my career, I have successfully managed over 500 ICSRs with a quality control accuracy exceeding 96%. My commitment to excellence has led to a 20% reduction in case turnaround time through the optimization of SOPs and case allocation redesign. I have also played a pivotal role in CAPA resolution initiatives and deviation investigations during client audits, showcasing my ability to lead and mentor teams effectively.

Currently, I oversee end-to-end ICSR processing at Parexel International, collaborating with global safety teams to ensure compliance and data integrity. My strong communication and leadership skills have enabled me to train new joiners and coordinate vendor deliverables, further enhancing the operational efficiency of my team.