Laxmipriya Samal
Business Process Lead
Bengaluru,KA
Summary
Highly motivated pharmacovigilance professional with over 7 years of experience in case processing, quality review, medical review, and workflow management. Proven track record in managing team, ensuring case quality, and meeting regulatory deadlines. Developed strong skills in a fast-paced, process-driven environment, with a focus on optimizing workflows and enhancing operational efficiencies. Demonstrated ability to analyze data, lead teams, and implement innovative solutions. Seeking an opportunity to transition into a new field where transferable skills can drive success and contribute to growth.
Overview
7
7
years of professional experience
16
16
years of post-secondary education
3
3
Languages
Work History
Business Process Lead (BPO 3)
TCS
09.2022 - Current
- Led a team of case processors in pharmacovigilance operations, ensuring data quality, adherence to SOPs, and timely project completion
- Developed and implemented training programs to improve team skills and knowledge in ICH-GCP, MedDRA coding, and quality review processes
- Monitored team performance, identified areas for improvement, and implemented corrective actions to enhance overall efficiency
- Working on internal quality review to meet client expectations.
Senior Drug Safety Associate (Level 2)
Bioclinica India Pvt Ltd
02.2020 - 08.2022
- Managed the processing of all types of adverse events (spontaneous, clinical trial, legal, literature) within agreed timelines
- Performed comprehensive data entry and medical coding using MedDRA and client-specific dictionaries
- Drafted medically accurate safety narratives for reported adverse events
- Conducted quality reviews to ensure data accuracy and adherence to regulatory requirements
- Provided training and mentorship to junior team members on case processing best practices
Junior Data Analyst
Cognizant Technology Solutions
09.2017 - 02.2020
- Processed and analyzed pharmacovigilance data using ARGUS and AWARE
- Identified and resolved data discrepancies to ensure data integrity
- Supported the creation of regulatory reports for submission to health authorities
Education
Master of Pharmacy - Pharmaceutical Analysis And Quality Assurance
Siksha ‘O’ Anusandhan University
Bhubaneswar, Odisha 04.2001 - 01.2017
Bachelor of Pharmacy - undefined
Institute of Pharmacy and Technology
Salipur, CuttackSkills
Pharmacovigilance Expertise: ICH-GCP, MedDRA, Data Entry, Case Processing, Quality Review, Data Analysis, Regulatory Reporting, Clinical Trial Safety Operations
Project Coordination: Workflow Management, Team Leadership, Productivity & Quality Tracking, Client Communication, Meeting Deadlines
Database: Proficient in Argus Safety Database, Proficient in Aris G Safety Database
Technical Communication: Technical writing, Medical Narrative Writing, Clear and concise communication with internal and external stakeholders
Proficient in MS Office: Proficient in MS Office Suite (Word, Excel, PowerPoint
Attributes
- Process Optimization Experience
- Multitasking Abilities
- Teamwork and collaboration
- Effective communication
- Problem-solving abilities
- Organizational skills
- Professionalism
- Task prioritization
- Analytical skills
- Self motivation
- Time management
- Decision-making
- Adaptability and flexibility
- Continuous improvement
- Relationship building
- Performance management
Disclaimer
I hereby declare that all the above given information is true and genuine to the best of my knowledge and belief.
Timeline
Business Process Lead (BPO 3)
TCS
09.2022 - Current
Senior Drug Safety Associate (Level 2)
Bioclinica India Pvt Ltd
02.2020 - 08.2022
Junior Data Analyst
Cognizant Technology Solutions
09.2017 - 02.2020
Master of Pharmacy - Pharmaceutical Analysis And Quality Assurance
Siksha ‘O’ Anusandhan University
04.2001 - 01.2017
Bachelor of Pharmacy - undefined
Institute of Pharmacy and Technology