Priyanka Ghume
Pune City East
Summary
Detail-oriented Drug Safety Associate recognized for achieving 100% quality in adverse event case processing and drug safety monitoring. Specialized in regulatory compliance with a proven track record of high productivity and efficient task completion. Strong critical thinking and problem-solving skills enhance effectiveness in drug safety operations. Excellent communication abilities ensure clarity and precision in all interactions.
Overview
7
7
years of professional experience
Work History
Drug Safety Associate/ SME
Cognizant technology solutions India Pvt . Ltd
01.2020 - 02.2025
- Oversaw safety case processes, including intake, triage, data entry, and quality assessment.
- Conducted quality reviews of ICSR submissions to verify accuracy and compliance.
- Generated and forwarded queries for clarification or missing information as needed.
- Mentored new hires, delivering training sessions on pregnancy cases and protocols.
- Ensured daily tasks and process flows adhered to established service level agreements (SLAs).
- Identified E2B errors, providing feedback for necessary corrections to associates.
- Collected root cause analyses and corrective action plans, leading sessions on error minimization.
- Implemented client amendments promptly, ensuring alignment with updated requirements.
Medical Coder
3 Gen Consulting services LLP
10.2017 - 09.2018
- Maintained current knowledge of coding changes and new regulations.
- Coordinated team activities to enhance productivity.
- Demonstrated expertise in medical coding principles and practices.
Education
B. Pharm -
Pune University
01.2017
Higher secondary certificate -
Maharashtra State Board
01.2013
Secondary school certificate -
Maharashtra State Board
01.2011
Skills
- Safety databases management
- Adverse event reporting
- Medical terminology expertise
- Case processing and MedDRA coding
- Narrative writing skills
- Microsoft Office proficiency
- Spreadsheet analysis and presentation
- Windows operating systems knowledge
- Speed typing proficiency
- GCP Compliance
- Team coordination and collaboration
- Planning and organizing tasks
- Good clinical practice
- Regulatory review
- Mentoring and training development
- Efficiency and productivity enhancement
- Continuous learning commitment
- Professional responsibility adherence
- Quality assessment techniques
- Effective communication skills
Languages
- Hindi
- Marathi
- English
Personal Information
- Date of Birth: 02/18/1996
- Gender: Female
- Nationality: Indian
- Marital Status: Married
Timeline
Drug Safety Associate/ SME
Cognizant technology solutions India Pvt . Ltd
01.2020 - 02.2025
Medical Coder
3 Gen Consulting services LLP
10.2017 - 09.2018
B. Pharm -
Pune University
Higher secondary certificate -
Maharashtra State Board
Secondary school certificate -
Maharashtra State Board
Similar Profiles
Jeevan DevadigaJeevan Devadiga
Process Executive at Cognizant Technology Solutions India Pvt LtdProcess Executive at Cognizant Technology Solutions India Pvt Ltd
KEERTHI GADDAMKEERTHI GADDAM
Process Executive – Data at Cognizant Technology Solutions India Pvt. Ltd.Process Executive – Data at Cognizant Technology Solutions India Pvt. Ltd.
ANUSHA PSANUSHA PS
Senior Manager at Cognizant Technology Solutions India Pvt LtdSenior Manager at Cognizant Technology Solutions India Pvt Ltd
Ranjeet YadavRanjeet Yadav
Team Lead at Datametica Solutions PVT LimitedTeam Lead at Datametica Solutions PVT Limited
Pawan PatilPawan Patil
Project Manager at Oceanic EoPs Technologies LLProject Manager at Oceanic EoPs Technologies LL