Open to opportunities

Jerath Kiran

@jerathkiran

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Dedicated Pharmacovigilance professional with 10+ years of global experience.

India

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What I'm looking for

I am looking for a role that fosters collaboration, innovation, and continuous learning in drug safety.

I am a dedicated Pharmacovigilance professional with over 10 years of global experience in drug safety and regulatory compliance. My expertise encompasses signal detection, ICSR processing, and aggregate safety reporting, ensuring adherence to FDA, EMA, and ICH-GCP guidelines. I have a proven track record in managing safety databases and leading cross-functional teams to deliver operational excellence.

Throughout my career, I have authored critical documents such as DSURs and PBRERs for global regulatory submissions, demonstrating my ability to navigate complex regulatory landscapes. My role as a Safety Aggregate Reporting Specialist at IQVIA has honed my skills in literature surveillance and stakeholder engagement, where I successfully supervised a team of over 40 professionals, driving quality reviews and performance reporting.

I am passionate about continuous improvement and have spearheaded initiatives to optimize processes and enhance team productivity. My educational background includes a Post Graduate Diploma in Pharmacovigilance and a Master of Pharmacy, which complements my extensive hands-on experience in the field.

Experience

Work history, roles, and key accomplishments

Current

Safety Aggregate Reporting Specialist 2

Current

IQVIA RDS (India) Pvt Ltd

Oct 2022 - Present (2 years 8 months)

Led as the primary author for Development Safety Update Reports (DSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) for global regulatory submissions. Headed literature surveillance projects, identifying Individual Case Safety Reports (ICSRs) and safety signals from scientific journals.

DSURs PBRERs Literature Surveillance Regulatory Submissions

Associate Manager – Safety Operations Team

IQVIA RDS (India) Pvt Ltd

Sep 2021 - Present (3 years 9 months)

Spearheaded revisions of Standard Operating Procedures (SOPs) and served as a Subject Matter Expert (SME) for pharmacovigilance initiatives. Monitored quality Key Performance Indicators (KPIs), supported change management, and drove productivity gains.

KPIs Change Management Process Optimization Team Leadership Stakeholder Engagement

Drug Safety Associate

IQVIA RDS (India) Pvt Ltd

Mar 2015 - Present (10 years 3 months)

Processed clinical and post-marketing adverse events in strict adherence to global compliance standards. Liaised with internal and external stakeholders to ensure timely safety reporting and efficient query resolution.

Adverse Events MedDRA

Education

Degrees, certifications, and relevant coursework

Jayamukhi College of Pharmacy

Master of Pharmacy, Pharmaceutics

Earned a Master of Pharmacy with a specialization in Pharmaceutics, focusing on the design, development, and evaluation of pharmaceutical dosage forms. This advanced degree provided comprehensive knowledge in drug formulation and delivery systems.

Clini India

Post Graduate Diploma, Pharmacovigilance

Completed a Post Graduate Diploma in Pharmacovigilance, gaining specialized knowledge in drug safety and adverse event monitoring. This program provided a foundational understanding of pharmacovigilance principles and practices.