Pratiksha More
Senior Drug Safety Analyst
Pune
Summary
Desiring Senior Process Associate and energetic individual highly skilled with case processing, trainer's activity and quality reviewer. Also, had 1 year experience of team handling.
Overview
8
8
years of professional experience
4
4
years of post-secondary education
Work History
Senior Process Associate
Tata consultancy services
Pune
05.2021 - Current
- Performed clinical trial cases and also used to for RAVE/iMedidata
- Responsible to closed and raised queries in CRF in rave
- Performed Medical devices cases and pregnancy cases
- Handled all types of cases (Serious-Fatal/LT, non-serious, SR, Clinical reports, Legal reports) determine the causality assessment and perform the labeling of the adverse events.
- Handling the special cases (Serious, non-serious, mother-baby (pregnancy) cases). Make significant contributions to projects relating to improvements in processes and Systems
- Identified and resolved process issues to drive optimal workflow and business growth.
- Conducted root cause analysis to enhance quality processes.
- Perform additional tasks / responsibilities as assigned delegated by the team lead / manager
- Met month-end reporting objectives and deadlines.
Junior Data Analyst
Cognizant technology Solutions
Pune
03.2018 - 05.2021
- Quality reviewer and trainer
- Participated in internal audits regarding quality management system.
- Assessed business requirements to create focused solutions.
- Developed diagrams to describe and lay out logical operational steps.
- Handled all types of cases (Serious-Fatal/LT, non-serious, SR, Clinical reports, Legal reports) determine the causality assessment and perform the labeling of the adverse events. Handling the special cases (Serious, non-serious, mother-baby (pregnancy) cases). Make significant contributions to projects relating to improvements in processes and Systems.
- Release the report to client through client safety database within regulatory timelines. Assessing the validity of case and rejecting the case if invalid adverse event .
- Handling whole Open action activity, responsible to generate Query letter to reporter/Consumer, when received any query from Central, sending all letters via Due diligence, Right Fax, Email and closed all the queries.
- Assignment of open action items in Argus core, taking follow up for Argus cases.
- Providing billing data, Dashboard and All TAT missed data of Open action item activity.
- Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports on the basis of seriousness criteria and priority basis from source documents with emphasis on timelines and quality
- Reviewed completed work for compliance with regulations.
- Completed data entry tasks with accuracy and efficiency.
- Corrected data entry errors to prevent duplication or data degradation.
- Produced monthly reports with advanced Excel spreadsheet functions.
- Increased data-entry productivity by maintaining detailed logs of data projects, identifying issues and improving them.
- Kept optimal quality levels to prevent critical errors and support team performance targets.
- Performed continuous evaluations of content and plans to enhance delivery and improve effectiveness.
- Developed effective training plans based on department needs and objectives.
- Supported productivity increase and business growth through new hire training and mentoring.
- Tracked attendance and evaluated progress for assigned trainees.
- Analyzed team performance and identified opportunities for additional training.
Education
Bachelor of Science - Pharmacy
MGV's S P H College of Pharmacy
Malegaon 08.2013 - 07.2017
Skills
Communication skill
Confident, Hardworking, resourceful
Self-motivated, ambitious, energetic with exceptional work ethics nd willing to go extra mile to achieve target
Creative, problem solving
Ethical, committed, innovative, yet consistent
Good at team work
Responsible person with positive attitude
Singing , Reading and cooking
Singing:
Performed at Mulshi's got talent at Pune, 2019
Performed in rewards and recognition event at Cognizant
Reading:
Reading provides a welcome relief from our dull, daily routine. It is an excellent pastime in which the rich and the poor alike can indulge in their spare time. I have read Many books till the time (Marathi, hindi and english). My favorite ones are Ikigai, Vapurza, Kasap, etc.
Timeline
Senior Process Associate
Tata consultancy services
05.2021 - Current
Junior Data Analyst
Cognizant technology Solutions
03.2018 - 05.2021
Bachelor of Science - Pharmacy
MGV's S P H College of Pharmacy
08.2013 - 07.2017