Rupa Shetty
Senior Safety Surveillance Associate
Palghar
Summary
Experienced Pharmacovigilance professional skilled in adverse event reporting, drug safety regulations, and database management. Strong background in medical coding, quality control, and regulatory compliance. Effective communicator and team player with a proven track record of ensuring data accuracy and collaborating cross-functionally. Adept at mentoring team members and optimizing performance. Seeking to leverage expertise in pharmacovigilance to contribute to organizational success.
Overview
7
7
years of professional experience
Work History
Senior Safety Surveillance Associate
Pfizer
6 2021 - Current
- Served as backup to the team manager, taking on leadership and oversight responsibilities, including workflow management, team coordination, and compliance with pharmacovigilance regulations. Managed escalations and contributed to strategic decision-making.
- Acted as a subject matter expert, liaising with key partners on safety data collection and reconciliation
- Led pharmacovigilance activities for adverse event reporting and safety assessment of Pfizer products, ensuring timely and accurate processing of individual case safety reports in compliance with regulatory requirements.
- Leveraged issue resolution and negotiation skills to contribute to training development, shape strategic direction, and advance continuous improvement initiatives.
- Collaborated with internal and external stakeholders to ensure precise and timely adverse event reporting.
- Initiated process improvement projects and training programs within the Pharmacovigilance department.
- Onboarded and trained new colleagues, providing oversight on case handling, data extraction, and analysis across teams.
Case Processing Associate
Tata Consultancy Services (TCS)
02.2020 - 06.2021
- Responsible for data entry and evaluation of individual case safety reports
- Processed incoming cases to meet timelines, including medical coding and safety narrative
- To handling query and response it appropriately, to raised urgent and non-urgent query communication about discrepancy and take confirmation to respected unit
- Mentored and guided Drug Safety Associates, ensuring proficiency in workflow tasks.
Safety Data Analyst
Cognizant Technology Solutions (CTS)
09.2017 - 02.2020
- Case book in, triaging, processing of Eudravigilance (EV) cases received from health authority across the globe
- Performing quality check of case against the source document and entering any data found relevant during assessment
- Monitoring the potential late cases of team members and taking necessary actions to avoid it
- Acted as a point of contact for license partner cases, ensuring timely review and entry of adverse event reports
- Automation of Spontaneous report cases received from License Partner (E2B cases).
Education
Bachelor of Pharmacy -
ST. John Institute of Pharmacy And Research, Mumbai University
Skills
Regulatory Compliance
References
Available upon request
Disclaimer
I hereby declare that the foregoing information is correct and complete to the best of my knowledge and belief.
Timeline
Case Processing Associate
Tata Consultancy Services (TCS)
02.2020 - 06.2021
Safety Data Analyst
Cognizant Technology Solutions (CTS)
09.2017 - 02.2020
Senior Safety Surveillance Associate
Pfizer
6 2021 - Current
Bachelor of Pharmacy -
ST. John Institute of Pharmacy And Research, Mumbai University
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