Ranisha Shinal Mendonca
Bengaluru
Summary
As a highly adaptable and self-motivated professional, I excel in learning and implementing new processes and trends. With a strong commitment to achieving targets, I thrive in collaborative environments and am always approachable for providing assistance. I take pride in my responsibility for enhancing team quality by identifying weaknesses and conducting targeted training to elevate performance. My proactive approach and dedication ensure the continual improvement and upscaling of teams.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Senior Pharmacovigilance Associate
Apcer Life Sciences India Ltd
01.2016 - Current
- Conducted booking and triaging of ICSR, ensuring efficient handling of incoming reports
- Performed accurate data entry of ICSRs in the Pharmacovigilance database, maintaining a high level of precision
- Entered source data in the database, coded information, and wrote comprehensive narratives, enhancing the quality of the database entries
- Generated follow-up letters, demonstrating proactive communication and follow-up procedures
- Conducted quality review of ICSRs in quality control case processing
- Prepared and submitted regulatory/partner submission reports, meeting all deadlines and compliance requirements
- Sent follow-up/administrative queries, ensuring complete and accurate information for ICSR management
- Reviewed literature articles and assessed them for identifying valid ICSRs, contributing to enhanced signal detection
- Ensured compliance to project guidelines and Company Standard Operating Procedures, maintaining high standards of quality and regulatory adherence
- Built and maintained strong relationships across functional units and company affiliates, fostering a collaborative work environment
- Stayed updated on changes to/new regulations affecting PVG activities, ensuring adherence to the latest regulatory requirements
- Carried out necessary administrative duties required for the job, ensuring smooth and efficient operations
- Collaborated with clinical data management teams for safety data reconciliation, ensuring data accuracy across databases
- Functioned as a Subject Matter Expert (SME), providing valuable guidance, mentoring, and structured training programs for new hires and junior associates
- Supported regulatory inspections and sponsor audits, ensuring PV documentation was audit-ready and TMF-compliant at all times
- Partnered with global stakeholders to ensure accurate distribution of expedited and periodic safety reports across clinical and post-marketing programs, ensuring global compliance
- Delivered refresher trainings and conducted performance assessments, significantly improving team knowledge and reducing processing errors
- Possessed hands-on experience in case processing and management, effectively managing the processing of safety cases.
Safety Operations Specialist 1
IQVIA
01.2014 - 12.2016
- Managed the processing of safety data in compliance with applicable regulations, guidelines, and Standard Operating Procedures (SOPs).
- Performed pharmacovigilance activities, including collecting and tracking incoming Adverse Events (AE)/endpoint information, determining initial/update status of incoming events, database entry, coding AE and products, and writing narratives, ensuring adherence to internal/project timelines.
- Tracked and reviewed Serious Adverse Event (SAE) documents for completeness and accuracy.
- Conducted data entry into tracking database and analyzed cases to generate safety queries, effectively communicating with sites and clinical operations team and ensuring timely follow-up for study-related documents and investigational reports.
- Processed and conducted quality review of cases, consistently following Standard Operating Procedures.
- Liaised with site personnel to obtain missing data/documents, ensuring completeness of records.
Scientist
AJ Hospital & Research Centre
01.2014 - 12.2014
- Operated and maintained Biochemistry and Haematology based instruments
- Ensured quality control by maintaining set standards and tolerance values of Analytical Instruments
- Processed patient samples in Biochemistry, Haematology, and Serology departments
- Conducted phlebotomy procedures with precision and care
- Handled sample accession process efficiently
Education
MS/M.Sc(Science) - BioChemistry
Manipal University
B.Sc - Medical Lab Technology
Manipal University
XIIth - English
CBSE
Xth - English
CBSE
Skills
- Data Processing
- Pharmacovigilance
- Clinical Research
- Drug Safety
- Clinical Data Management
- Medical Coding
- Clinical Trials
- Data Management
- Quality control
- Data reconciliation
- Team training
Certification
- Fundamentals GCP Accreditation
- Advanced MedDRA Coding
Accomplishments
- Received Applause Award for teamwork, effective management of deliverable and training new joiners.
- Bravo award for effective management and SME skills.
- Recognition award for superior performance at work.
Projects
Clinical profile of acute kidney injury in a pediatric intensive care unit from Southern India, 31 Days, A prospective observational study based on clinical profile of acute kidney injury in a pediatric intensive care unit from Southern India.
Timeline
Senior Pharmacovigilance Associate
Apcer Life Sciences India Ltd
01.2016 - Current
Safety Operations Specialist 1
IQVIA
01.2014 - 12.2016
Scientist
AJ Hospital & Research Centre
01.2014 - 12.2014
MS/M.Sc(Science) - BioChemistry
Manipal University
B.Sc - Medical Lab Technology
Manipal University
XIIth - English
CBSE
Xth - English
CBSE