Aayushi Gupta
Gurgaon,India
Summary
To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
4
4
years of professional experience
6
6
years of post-secondary education
Work History
Pharmacovigilance Assistant
Elites Safety Sciences
Gurgaon, Haryana
12.2021 - 06.2022
- Enter data into client safety database ensuring accurate entry of assigned cases average 7-8 cases per day..
- Verify all case information entered at Book-in/Triage ,including confirmation of MedDRA coding of adverse events, according to project specific guidelines.
- Code concomitant medications, additional suspect medications and medical history
- Write narrative per client template, query formulations, remove queries that have been answered.
- Provide support to other product team members as needed.
- Maintain thorough understanding of all product protocols and scope of work for clinical studies.
- Communicate problems and issues to product lead in timely manner.
- Actively participates in project team meetings as required, providing process improvements suggestions.
- Adheres to required timelines for completion of adverse event data entry.
- Conducted research, gathered information from multiple sources and presented results.
- Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting.
Executive Quality Assurance
Abbott Healthcare Pvt. Ltd.
Baddi, Himachal Pradesh
07.2018 - 12.2021
- 1. Training Management
- To prepare training plan of employees as site as per their job roles.
- To provide training metrics to Senior Leadership Team.
- To provide induction to new joinees at plant and introduce them with site procedures. - To prepare plan for yearly GxP trainings.
- To monitor training compliance at site by providing list of training tasks due for dates and getting them completed before it gets past due.
- To act as system site administrator and to coordinate with other department training coordinators to resolve issue faced by people at site in training.
- To resolve ISOtrain (Learning management system) issues in coordination with regional and global team. - To ensure training projects compliance.
- To align and implement site training procedure with latest guidelines.
- 2. Documentation
- To prepare and review documents related to site procedure and upload in software for master document (Standard Operating Procedures, Standard Testing Procedure) and distribution purpose.
- To ensure compliance of logbooks and records.
- To provide documents and data to regulatory.
- To approve artworks as per latest guidelines by regulatory along with regulatory and packaging development team.
- To act as system site administrator for DARIUS software and to coordinate with Amplexor team for issue resolving.
- To ensure archival of Batch Processing records.
- 3. Quality Management System
- To ensure documentation and execution of tasks of Change Control though Track wise Application.
- To ensure effective implementation of QMS through SolTRAQs application system.
- To ensure effective implementation of Change proposed.
Education
Master of Pharmacy - Drug Regulatory Affairs
DIPSAR
Delhi 08.2016 - 07.2018
Bachelor of Pharmacy -
M.I.E.T.
Meerut 08.2012 - 07.2016
Skills
Microsoft Office (MS Word, MS Excel Advance)
Research Implementation
Market Research and Documentation
Root Cause Analysis
Quantitative Analysis
Teamwork and Collaboration
Accomplishments
- Abbott Excellence Award for representing training system in MHRA Inspection.
- Abbott Excellence Award in IPQA.
- Recognized for implementing the project on Effective implementation of Training system at site.
Timeline
Pharmacovigilance Assistant
Elites Safety Sciences
12.2021 - 06.2022
Executive Quality Assurance
Abbott Healthcare Pvt. Ltd.
07.2018 - 12.2021
Master of Pharmacy - Drug Regulatory Affairs
DIPSAR
08.2016 - 07.2018
Bachelor of Pharmacy -
M.I.E.T.
08.2012 - 07.2016
Publications
Review article on "Role of IPR for commercialization of pharma products".
Pages 522-531, 2018, Vol 7, Issue 6 - The Pharm Innovation Journal
Review article on "Cosmetics: Regulatory and market scenario for US and India".
Pages 164-169, 2018, Vol 7, Issue 6 - The Pharm Innovation Journal
Publications
Review article on "Role of IPR for commercialization of pharma products".
Pages 522-531, 2018, Vol 7, Issue 6 - The Pharm Innovation Journal
Review article on "Cosmetics: Regulatory and market scenario for US and India".
Pages 164-169, 2018, Vol 7, Issue 6 - The Pharm Innovation Journal