Meera Vyas
@meeravyas
Clinical Research and Pharmacovigilance professional dedicated to patient safety.
GermanyWhat I'm looking for
I am a Clinical Research and Pharmacovigilance professional with extensive experience in regulatory compliance, quality control, and patient safety. My journey began with a Doctor of Pharmacy degree, which laid the foundation for my expertise in clinical operations and safety database management. I have a proven track record of enhancing compliance and patient safety through effective training and cross-functional collaboration.
Throughout my career, I have held various roles, including Report Reviewer and Clinical Research Associate, where I successfully managed site visit reports and conducted quality control audits. My analytical skills have enabled me to leverage data-driven insights to identify risks and improve workflow efficiency. I am passionate about training teams and ensuring adherence to regulatory standards, which has significantly contributed to the success of the projects I have been involved in.
Experience
Work history, roles, and key accomplishments
Report Reviewer – Site Report Management
Lambda Therapeutic Research Ltd.
Feb 2022 - Present (3 years 6 months)
Reviewed and managed site visit reports across all clinical trial phases for global projects in compliance with ICH-GCP and sponsor requirements. Trained CRAs on protocol interpretation, annotation strategies, and site-visit report writing, improving data quality and regulatory compliance.
Pharmacovigilance Associate
APCER Life Science Ltd.
Jun 2019 - Present (6 years 2 months)
Processed Individual Case Safety Reports (ICSRs) from global and domestic clients using ARISg. Conducted case triage, data entry, medical coding (MedDRA), and narrative writing for adverse event reports.
Pharmacovigilance Intern
Cliantha Research Ltd.
Feb 2018 - Present (7 years 6 months)
Validated in-house Pharmacovigilance database software (CodePV) and ensured compliance with Good Pharmacovigilance Practices (GVP). Conducted training sessions for new employees on pharmacovigilance activities and SOPs.
Clinical Trial Assistant
Lambda Therapeutic Research Ltd.
Monitored study compliance through tracker analysis, identifying and mitigating protocol deviations. Managed Trial Master File (TMF) and Site Master File (SMF) documents in electronic and paper formats.
Clinical Research Associate – Quality Control
Lambda Therapeutic Research Ltd.
Conducted quality control audits in accordance with ICH-GCP (R2), supporting risk-based monitoring implementation. Leveraged interactive analytics and Key Risk Indicator (KRI) dashboards to review site and study-level data, identifying protocol deviations, patient safety concerns, and data integrity risks.
Education
Degrees, certifications, and relevant coursework
K.B. Institute of Pharmaceutical Education and Research
Doctor of Pharmacy (PharmD), Pharmacy
2013 - 2019
Completed a Doctor of Pharmacy program, equivalent to a Master’s in Pharmaceutical Sciences as per EU standards. Conducted a Master’s Thesis on ‘Prevalence of known cases of Diabetes Mellitus by use of medicine and evaluation of pharmaceutical care in diabetic patients.’
Tech stack
Software and tools used professionally
Availability
Location
GermanyAuthorized to work in
Job categories
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