Experienced Drug Safety Associate with a Doctor of Pharmacy degree and a strong foundation in pharmaceutical sciences, clinical research, and regulatory compliance. Postgraduate in Clinical Research, Drug Safety, and Pharmacovigilance from the Academy of Applied Pharmaceutical Sciences, Toronto, and Health Care Administration and Service Management from Conestoga College, Kitchener.Possess hands-on experience in adverse event data management, safety reporting, and adherence to industry standards and guidelines in drug safety and Pharmacovigilance. Skilled in clinical trial management, patient safety, and project coordination, ensuring rigorous protocol adherence and successful subject recruitment for clinical research outcomes.Proficient in PointClickCare for maintaining accurate patient records and adhering to confidentiality standards such as HIPAA. Experienced in MedDRA Coding, project coordination, and utilizing databases like Micromedex, Medscape, and VigiBase for drug-related issues. Skilled in document control procedures, timely initiation of safety reports, and query management for comprehensive reporting.Dedicated to improving patient outcomes and ensuring compliance with FDA guidelines and ICH-GCP regulatory standards. Familiar with clinical research methodologies and Pharmacovigilance activities, including ICSR and PSUR reporting, clinical trials oversight, and maintaining meticulous clinical documentation to support regulatory compliance and patient safety initiatives.Actively seeking opportunities to leverage expertise in clinical research, Pharmacovigilance, risk management, and safety surveillance to contribute to innovative advancements in drug safety and Pharmacovigilance at a forward-thinking organization within the life sciences industry.
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Health Care AideSaint Luke'S Place Long- Term Care 2020 - 2024Kitchener, Ontario, CanadaMaintain accurate and up-to-date patient progress records in PointClickCare.Adhere to strict confidentiality standards and ensure compliance with HIPAA guidelines.Effectively communicate with patients and families, providing clear instructions and addressing inquiries.Offer empathetic and emotional support, fostering a compassionate environment.Assist with fundamental patient care needs, prioritizing well-being and comfort.Collaborate with registered nurses to monitor vital signs and assess patient health.Collect specimens for lab testing, ensuring accuracy in collection and processing.Record detailed medical histories to support informed decision-making by the healthcare team -
Drug Safety AssociateBioclinica 2018 - 2019Mysore, Karnataka, IndiaLed the timely initiation of drug safety reports, ensuring adherence to strict timelines and SOP's.Ensured precise data entry and coding of adverse event records, maintaining strict SOP compliance standards.Developed a streamlined process to receive and accurately enter adverse event data into the ARISg safety database.Evaluated non-expedited reports within defined time frames, strictly adhering to regulatory guidelines.Reviewed case reports thoroughly for seriousness, global listedness, and causality factors.Identified missing clinically relevant information in case reports and initiated prompt follow-up queries.Managed the efficient process of sending queries and follow-up requests to collect essential information.Maintained high data accuracy and integrity, ensuring compliance with regulatory requirements and industry SOPs
Sneha Mathew Education Details
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Clinical Research, Drug Safety And Pharmacovigilance -
Health/Health Care Administration/Management -
Ks Hegde Hospital, Nitte UniversityPharmacy
Frequently Asked Questions about Sneha Mathew
What is Sneha Mathew's role at the current company?
Sneha Mathew's current role is Clinical Research | Drug Safety | Pharmacovigilance.
What schools did Sneha Mathew attend?
Sneha Mathew attended Academy Of Applied Pharmaceutical Sciences, Conestoga College, Ks Hegde Hospital, Nitte University.
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Sneha Mathew
Greater Toronto Area, Canada1xperigo.com -
1cibc.com
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Sneha Mathew
Senior Funding Analyst.Omvic - Certified In Automotive Law & Ethics.(C.A.L.E)Stoney Creek, On
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