2022 - present: Managed the distribution of safety notifications

Role: Drug Safety Assistant

Customer: ICON plc

Place of work: Mannheim, Germany

Tasks:

• Managed the distribution of safety notifications (SAE, AESI, AR) via safety mailboxes, ensuring timely communication.
• Conducted daily surveillance of safety reporting mailboxes, administrative documentation,reducing response time to critical safety issues by 30%.
• eTMF triage, reconciliation,and quality review for clinical trial documents.
• Procedure Compliance: Ensured compliance with ICH/GCP guidelines, maintaining high regulatory standards.
• Successfully triaged over 20000 patient cases, contributing to a 90% improvement in Clinical trial efficiency.
• Phase III clinical trial for Oncology drugs.
• Phase III clinical trial for Infectious disease.
• Phase IV Post marketing surveillance for Infectious diseases.
• Conducted EudraVigilance Acknowledgement of Receipt (AoR) and MHRA AoRs, achieving a 100% compliance rate with regulatory requirements.
• Triaged, coordinated safety data using ARGUS, eTMF-Phlex, Veeva Vault, and SharePoint, improving data accuracy by 25
• Collaborated with cross-functional teams to prioritize cases based on clinical urgency and protocol requirements
• Maintained accurate data entry for SAEs and miscellaneous logs assigned, enhancing data integrity.
• Analyzed case and query data, providing insights to improve safety reporting processes.
• Quality Control: Conducted quality control of case study reports,project smooth execution achieving a 98% accuracy rate in documentation.
• Reconciliation for Inspection Readiness: Reconciled eTMF and safety tracking tools for inspection readiness, ensuring coherence, document managment system,and resolution of queries, which contributed to successful audits.
• Filing Compliance: Maintained high filing quality and compliance for all documentation in the eTMF, achieving a 100% compliance rate in audits.
• Monitored and tracked safety reports in safety systems (SLTs, SET, Safety database), improving tracking efficiency by 20%.
• Coordinated with translation vendors (Medax, T-Blue, Transline, Advento, ILS)for timely manners, improving global reporting.
• Regulatory Submissions participation: Performed case booking, audits and regulatory submissions, contributing to a 100% ontime submission rate.
• Generated Monthly Executive Overview Reports (MEOR) for Project Managers,enhancing project oversight

Role: Clinical Pharmacist

Customer: Sri Ramakrishna institute of Para-medical sciences

Place of work: Coimbatore, India

Tasks:

• Practiced procedures according to ICH/GCP regulations, ensuring clinical and safety compliance.
• Managed drug regimens and interventions for drug-drug and drug-food interactions, optimizing patient outcomes.
• Applied knowledge of pharmacokinetics and pharmacodynamics to improve treatment efficacy.
• Conducted causality assessments and risk determinations, mitigating adverse drug reactions.
• Performed medication history interviews, identifying and correcting medication errors.
• Provided patient counseling in outpatient, bedside, and community settings, enhancing treatment adherence.
• Monitored and reported adverse drug reactions, contributing to patient safety.
• Conducted pharmacoeconomic evaluations to optimize costeffective treatment plans.
• Led antibiotic stewardship projects, promoting responsible use and reducing resistance.
• Practiced procedures according to ICH/GCP regulations, ensuring clinical and safety compliance.
• Managed drug regimens and interventions for drug-drug and drug-food interactions, optimizing patient outcomes.
• Applied knowledge of pharmacokinetics and pharmacodynamics to improve treatment efficacy.
• Conducted causality assessments and risk determinations, mitigating adverse drug reactions.
• Performed medication history interviews, identifying and correcting medication errors.
• Provided patient counseling in outpatient, bedside, and community settings, enhancing treatment adherence.
• Monitored and reported adverse drug reactions, contributing to patient safety.
• Conducted pharmacoeconomic evaluations to optimize costeffective treatment plans.
• Led antibiotic stewardship projects, promoting responsible use and reducing resistance.