Shilpa Shree

Drug Safety Scientist I with 8.5 years of pharmacovigilance experience specializing in ICSR intake, triage, medical coding (MedDRA), narrative writing and quality review for spontaneous, clinical and PCFR reports. Proven subject-matter expert who drives data accuracy and regulatory compliance, mentor's associates, leads root-cause analyses and CAPA implementation, and supports client training and QC reviews. Proficient in ARISg, Argus, AgXchange/IRT and MS Office; dependable under tight timelines to deliver high-quality safety data.

Drug Safety Scientist I at Qinecsa India Pvt. Ltd. (Mar 2023 – Present)

• Led case intake, duplicate checks, registration and triage; ensured case validity and completeness per SOPs and regulatory timelines.
• Evaluated seriousness, expectedness/listedness and causality; wrote and quality-checked medically relevant narratives and database entries.
• Performed MedDRA/WHO-DD coding for AEs, medical history, drugs and labs; processed E2B submissions and managed case merges/nullifications.
• Monitored quality trends, conducted root cause analyses, prepared CAPAs and coached associates to meet quality targets and turnaround goals.
• Participated in safety system testing and contributed to SOP/manual development to streamline processes and reporting.
• Oversaw and perform ICSR case processing, seriousness assessment, MedDRA/WHODrug coding, narrative writing, and data validation.
• Reviewed E2B transmissions, performed duplicate checks, and ensured regulatory compliance.

Senior Drug Safety Associate at Qinecsa India Pvt. Ltd. (Jun 2017 – Aug 2018), (Mar 2021 - Mar 2023)

• Quality reviews, intake and triage of ICSRs across sources: spontaneous, clinical trials, PSPs, pregnancy, pediatric, and device complaints
• Verified medical narratives for consistency; ensured completeness and data integrity
• Collaborated with compliance teams in closing CAPA actions, audit remediation to uphold escalation timelines and quality standards

Drug Safety Associate at Qinecsa India Pvt. Ltd. (Jul 2015 – Jun 2017)

• Managed case intake, triage, data validation, seriousness assessment, duplicate searches
• Executed medical coding (MedDRA, WHODD, proprietary dictionaries) and authored narratives
• Assessed individual reports for validity and expedited-reporting requirements

Safety specialist at PPD Bangalore, Karnataka (Jan2019 – Jun 2019)

• Processed Serious Adverse Events (SAEs) and supported clinical safety activities to ensure timely reporting and compliance with corporate and regulatory requirements.
• Reviewed SAEs, performed database entry, tracked cases, wrote narratives and requested follow-up from sites to ensure complete and accurate records.
• Notified expedited safety reports to regulatory authorities, ethics committees and principal investigators within required timelines.
• Coordinated with project teams, clients and investigators regarding SAE activities and supported preparation/review of regulatory reports.
• Coded adverse events and processed literature-derived reports per program and regulatory requirements.
• Provided project-specific safety training, adhered to SOPs/ICH GCP and communicated effectively with team members and stakeholders.

Bachelor of Pharmacy in Pharmacy – Sarada Vilas College, Mysore