Headline

Pharmacovigilance Operations Specialist | Drug Safety & Clinical Safety | ICSR Processing • Regulatory Compliance • Audit Readiness • CAPA • Signal Detection | Quality & Process Improvement

About

I am a Pharmacovigilance Operations Specialist with over 9 years of experience in leading global drug safety operations, quality compliance, and regulatory reporting in line with ICH-GCP standards. My expertise lies in eliminating major case backlogs, redesigning safety intake systems, and driving quality improvements of over 40% through structured CAPA and root-cause programmes. I thrive in dynamic environments and am passionate about ensuring patient safety while navigating complex regulatory landscapes. My goal is to leverage my skills in pharmacovigilance to contribute to innovative healthcare solutions. I am currently seeking full-time opportunities in Bangalore, Karnataka, and am excited to connect with like-minded professionals.

Location

Bengaluru

AI stack

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Work experience

Pharmacovigilance Operations Specialist III at Caidya, Dec 2021 - Apr 2026 · 4 yrs 5 mos, Thiruvananthapuram, Directed pharmacovigilance operations across global clinical and post-marketing programmes. Managed approximately 90 safety cases monthly while ensuring regulatory compliance and database integrity. Oversaw adverse event management, regulatory reporting, and quality oversight. Drove process improvements and system optimization to enhance operational efficiency. Ensured inspection readiness and adherence to safety surveillance protocols.

Pharmacovigilance Operations Specialist III at Caidya, May 2021 - Dec 2021 · 8 mos, Trivandrum, In my role at CAIDYA, I directed pharmacovigilance operations, ensuring regulatory compliance and safety surveillance across global clinical and post-marketing programs. I managed safety cases, focusing on adverse event management and quality oversight. My commitment to process improvements and system optimization contributed to operational consistency across multiple studies and safety platforms. Additionally, I played a key role in mentoring new team members, enhancing team collaboration and knowledge-sharing.

Pharmacovigilance Specialist at Caidya, Jun 2019 - Apr 2021 · 1 yr 11 mos, India, In my role at Caidya, I specialized in pharmacovigilance, focusing on case processing and regulatory report generation. I was responsible for pulling line listings for PSUR/DSUR preparations and providing key performance indicators for project quality. My experience with UAT testing in Argus and other EDC platforms enhanced the overall safety data management process.

Operational Specialist at IQVIA, Dec 2018 - May 2019 · 6 mos, India, Conducted high-volume pharmacovigilance activities for clinical trial and post-marketing programmes. Delivered accurate safety data management and regulatory reporting in line with global regulations. Supported narrative development and case reconciliation for expedited reporting. Prepared submissions while maintaining a strong record of productivity and quality oversight. Collaborated with cross-functional teams to meet client requirements and enhance service delivery.

Drug Safety Associate at IQVIA, Nov 2016 - May 2019 · 2 yrs 7 mos, On-site, My career in pharmacovigilance began at IQVIA, where I developed a technical foundation in global drug safety while supporting clinical trial and post-marketing programs for multiple international clients. As my experience grew, I became recognized for consistently delivering high-quality work under demanding timelines. I regularly supported complex case processing, quality reviews, and reconciliation activities while collaborating with physicians, clinical teams, and global stakeholders to resolve discrepancies and maintain accurate safety data. My commitment to quality, productivity, and continuous improvement resulted in multiple performance awards and increasing responsibilities throughout my progression. Key Contributions • Earned multiple organizational awards for consistently exceeding productivity and quality expectations while helping eliminate case backlogs ahead of project deadlines. • Processed high volumes of adverse event and serious adverse event reports, managing complete ICSR lifecycles including data entry, MedDRA coding validation, follow-up activities, reconciliation, and regulatory reporting. • Conducted detailed quality control reviews, investigated discrepancies, and ensured compliance with global regulations, SOPs, and client-specific requirements. • Partnered with safety physicians, clinical operations teams, and external stakeholders to resolve complex case queries and support timely regulatory submissions. • Maintained exceptional productivity while consistently meeting aggressive turnaround times and delivering accurate safety documentation within regulatory reporting timelines. • Built expertise across multiple pharmacovigilance systems, strengthening data integrity and supporting reliable safety surveillance activities throughout the product lifecycle.

Education

Bachelor of Engineering, Bioengineering and Biomedical Engineering, Rajalakshmi Engineering college

Diploma of Education, Biocon KGI Certificate Program in Biosciences, Biocon Academy