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Igna Thankachan

@ignathankachan

Highly skilled Clinical Research Professional with extensive trial coordination experience.

Canada

What I'm looking for

I am looking for a role that fosters collaboration, innovation, and professional growth in clinical research.

I am a Clinical Research Professional with over 2 years of experience in coordinating clinical trials and managing regulatory submissions. My expertise lies in ensuring data integrity and compliance within both hospital and pharmaceutical settings. I have a proven ability to oversee essential document processes and manage safety data, collaborating effectively with multidisciplinary teams to ensure efficient study conduct.

Throughout my career, I have demonstrated strong adherence to ICH-GCP guidelines and regulatory requirements. My role as a Drug Safety Associate at IQVIA involved processing high volumes of Individual Case Safety Reports (ICSRs) and conducting aggregate safety reviews, ensuring 100 percent compliance with regulatory timelines. I have also contributed to the management of Trial Master Files (TMFs) and supported regulatory inspections, showcasing my commitment to maintaining audit-ready documentation.

In addition to my professional experience, I have published research on medication reconciliation in oncology and cardiology, further solidifying my knowledge in the field. I hold a Master of Pharmacy and am a Certified Clinical Research Professional (CCRP), expected to be certified by 2025. I am passionate about advancing clinical research and contributing to innovative healthcare solutions.

Experience

Work history, roles, and key accomplishments

IQ

Drug Safety Associate

IQVIA

Mar 2023 - May 2024 (1 year 2 months)

Processed high volumes of Individual Case Safety Reports (ICSRs) for oncology, cardiovascular, and vaccine studies, ensuring 100 percent compliance with regulatory timelines. Managed Trial Master Files (TMFs) in Veeva Vault and supported regulatory inspections, demonstrating strong adherence to compliance standards.

BI

Drug Safety Associate

Bioclinica

Mar 2021 - Jun 2022 (1 year 3 months)

Drafted Confidentiality Disclosure Agreements (CDAs) and Clinical Trial Agreements (CTAs), supporting contract negotiation processes. Managed site-qualification visits and submitted Research Ethics Board (REB) applications, ensuring regulatory compliance for study initiation.

Education

Degrees, certifications, and relevant coursework

SS

St. James College of Pharmaceutical Sciences

Master of Pharmacy, Pharmacy

Completed a Master of Pharmacy degree, focusing on advanced pharmaceutical sciences. Gained in-depth knowledge and practical skills relevant to the field.

SS

St. James College of Pharmaceutical Sciences

Bachelor of Pharmacy, Pharmacy

Obtained a Bachelor of Pharmacy degree, building a foundational understanding of pharmaceutical principles and practices. Developed essential skills for a career in pharmacy.

Tech stack

Software and tools used professionally

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