Sayali Vishwas Deshpande
Pune
Summary
Dedicated Pharmacovigilance associate with 10 years of experience in drug safety, and regulatory compliance. Proven track record in leading aggregate safety reports, managing adverse event reporting, and ensuring global adherence to safety protocols. Expertise in collaboration with cross-functional teams to enhance patient safety and product efficacy.
Overview
6
6
years of professional experience
Work History
Senior Pharmacovigilance Associate
Cognizant Technology Solutions
11.2019 - Current
- Led aggregate safety reporting including authoring and finalizing PSURs, DSURs, Risk Management Plans, and additional regulatory documentation.
- Oversaw quality control of ICSR processing, ensuring compliance with regulatory reporting timelines.
- Facilitated cross-functional teams, mentoring junior staff, and representing the company in Health Authority audits and inspections.
- Supported medical safety assessment and contributed to product-specific safety guidelines.
- Worked extensively with MedDRA coding, Argus
Pharmacovigilance Associate
Tata Consultancy Services
Pune
07.2019 - 11.2019
- Processed and analyzed adverse event reports from clinical trials and post-marketing studies.
- Authored and reviewed safety deliverables (e.g., aggregate safety reports, safety data responses).
- Supported regulatory inspections and business partner audits.
Education
Bachelor of Pharmacy -
Shivaji University
Kolhapur01.2015
Skills
- Pharmacovigilance
- Drug Safety Analysis
- Aggregate Report Authoring
- Regulatory Compliance
- Risk Assessment
- Safety Management
- Clinical Research
- Case Processing
- MedDRA coding
- Argus Safety Database
Additional Information
Familiarity with Excel, PowerPoint, Word, and data management tools., Experience with Argus., Willingness to travel internationally and participate in professional development.
Timeline
Senior Pharmacovigilance Associate
Cognizant Technology Solutions
11.2019 - Current
Pharmacovigilance Associate
Tata Consultancy Services
07.2019 - 11.2019
Bachelor of Pharmacy -
Shivaji University