Headline

Senior Quality Analyst

About

As a Quality and Compliance Consultant at IBM, I leverage my extensive experience in pharmacovigilance and healthcare management to ensure the highest standards of quality and compliance across various industries. With over 2 years of experience in this role, I have successfully managed complete investigation processes related to quality and compliance controls, delivering accurate and timely results. Prior to joining IBM, I worked as a Senior Medical Safety and Reporting Specialist at Alcon, where I applied my pharmacovigilance skills to monitor and report adverse events related to pharmaceutical products. I also hold a Bachelor of Pharmacy degree from Periyar College of Pharmaceutical Sciences and an Advanced SAS Programming certification from Epoch Research Institute Chennai. My goal is to continue contributing to the advancement of quality and compliance in the healthcare sector.

Location

Greater Bengaluru Area

AI stack

antigravity

claude code

Work experience

Quality and Compliance Consultant | ISO 9001:2015 QMS Certified Lead Auditor at IBM, Apr 2023 - Present · 3 yrs 7 mos, Bengaluru, Karnataka, India, Responsible for handling clients across industries within the quality space. Manage complete investigation process related to quality and compliance controls.

Process Expert at Alcon, Aug 2022 - Apr 2023 · 9 mos, Bangalore Urban, Karnataka, India

Senior Medical Safety and Reporting Specialist at Alcon, Dec 2019 - Aug 2022 · 2 yrs 9 mos, Greater Bengaluru Area

Operations Specialist/Quality Reviewer/SME at IQVIA, Aug 2016 - Dec 2019 · 3 yrs 5 mos, Bengaluru Area, India,  Review all forms and documents pertaining to a case for errors, missing information, legibility.  Encode verbatim terms using MedDRA for patient history, product indication, death information screen, and event term information.  Enter labelling information for all client suspect products.  Responsible for writing narrative summaries on reported adverse event cases.  Responsible for completing the adverse event case; and sending the updated and related documents or information to Medical Review Physician.  Perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOPs), conventions and client policies.  Plan, organize, and manage daily work to meet service level timelines and deliverables.  Work with the Safety Review team lead to escalate issues or tasks outside the normal scope of work.  Entering datas in the safety databases and checking for further processing and duplicates of the cases.

Safety Reviewer at Accenture, Sep 2013 - Jul 2016 · 2 yrs 11 mos, Chennai, Tamil Nadu, India, CRF reviewing ,Adverse Events data analysis and Reporting to Regulatory Authorities

Student at Epoch Research Institute India Pvt. Ltd., Nov 2012 - May 2013 · 7 mos, Chennai, Pursued SAS education

Education

Bachelor of Pharmacy (B.Pharm.), Pharmaceuticals, Periyar College of Pharmaceutical Sciences

Higher Secondary Studies (11th & 12th std), Biology, Maths and Physics, Nehru Matriculation Higher Secondary School