Souhardya Sen
Senior Associate at Wipro | Quality and Regulatory Investigator - PMS | Medical Device Complaint Handling Expert| EU MDR | ISO 13485:2016 | CFR 820 | Subject Matter Expert (SME) | SAP | Track wish | Salesforce|
- Role
- Senior Associate at Wipro
- Location
- Kolkata, IN
- LinkedIn followers
- 500 followers
About Souhardya Sen
I\'m working as a Senior Associate, at Wipro, Kolkata. Dedicated professional with 3+ years of experience in Post Market Surveillance (PMS), specializing in Medical Device with expertise in Regulatory Compliance, Complaint Investigation, Risk Assessment, Technical Writing, and Cross-Functional Collaboration to drive positive outcomes.# Familiarity with 21 CFR 820, 21 CFR 803 and other medical device regulations.# Experience of conducting investigations of discrimination complaints, Proficient with QMS software like Track Wise, Salesforce, SAP, EDHT, EDMR. Activities -* Good knowledge of Medicine and Drug * Interaction with people * Good command over handling medical equipment * work Under stressed condition * Disciplined and Honest * Loyal toward work * Punctual \"I am always upgrading myself to be better than yesterday as learning has no limits!\" Drug Safety Associate with a history of working in the information technology and services industry. Experienced in Oracle Database, Argus Safety, Track Wish. Hands-on experience in MS Office application like Excel, Power Point and Word.
Experience
Senior Associate
Mar 2023 — Present · Kolkata, IN
Education
Guru Nanak institute of pharmaceutical sciences and technology
B.pharm
2017 — 2021
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