Manoj Patil
Operation Specialist 2 @IQVIA
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WORK HISTORY
Operation Specialist 2 @IQVIA
Acted as Safety Workflow Lead for multiple clinical studies, ensuring adherence to global regulatory standards.Designed and implemented pharmacovigilance workflows, improving operational efficiency and compliance across diverse projects.Led study start-up and close-out activities, including CRF design, data archival, and documentation for seamless project execution.Managed device-specific reporting (MDCG) and coordinated regulatory submissions to global authorities, achieving 100% compliance with timelines.Partnered with IT teams to configure and optimize ARGUS safety database for complex drug-device hybrid studies.Served as Subject Matter Expert (SME), mentoring and training new team members to strengthen capability and knowledge retention.Delivered process improvements and quality enhancements, driving higher accuracy in adverse event reporting.
EDUCATION
North Maharashtra University
b.pharmcy , Pharmacy
ABOUT MANOJ PATIL
With over a decade of experience in pharmacovigilance and clinical safety operations, I specialize in ensuring patient safety across drugs, medical devices, vaccines, and IVDs. My expertise spans end-to-end clinical trial lifecycle management, post-marketing surveillance, and driving regulatory compliance for global submissions.I’m passionate about optimizing safety workflows, building robust SOPs, and configuring databases that enhance data integrity and operational efficiency. Recognized for delivering impactful results in oncology clinical trials, device-specific reporting, and stakeholder engagement, I thrive on creating solutions that meet stringent regulatory standards.As a subject matter expert, I provide thought leadership and mentorship, fostering high-performing, cross-functional teams that deliver excellence in clinical safety.
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