Santosh Samal
Mumbai
Summary
Experienced and dedicated Data Analyst with 6+ years of experience in Pharmacovigilance, Clinical Data Monitoring, and identifying efficiencies and problem areas within data of Post Marketing Surveillance of drugs and Patient safety data. Proven track record of generating summary documents for senior management for monthly and quarterly compliance reporting. Seeking a challenging career to apply skills in an innovative and simplified process. Strong team player with excellent communication skills.
Overview
7
7
years of professional experience
Work History
Data Analyst
Cognizant Technology Solutions India Private Limited
Mumbai
04.2023 - Current
- Quality control check of all adverse event safety reports that are received from the investigational sites or from the post-marketing sector is reported in accordance with the ICH-GCP standards and also by the standard operational procedures.
- Provided support for audit/inspection activities, quality investigations, CAPA creation, and implementation for assigned country/territory.
- Served as the Subject Matter Expert (SME) for any project-related issues and queries from the users, and provided expert guidance and solutions to resolve the related challenges.
- Actively managed client communication, including handling client calls and ensuring their needs were addressed promptly and professionally.
- Prepared Meeting Minutes for internal and client meetings to document discussions, action items, and key takeaways, fostering clarity and accountability within the team.
Junior Data Analyst
04.2020 - 04.2023
- Recording and reporting adverse reactions received from healthcare professionals, drug company representatives, and patients in the form of clinical trials and spontaneous reports, including clinical data entry into the electronic database.
- Ensuring data accuracy, clinically valid case assessment, regulatory reporting status assessment, and follow-up are completed on pharmacovigilance cases.
- Responsible for global pharmacovigilance activities to support data safety and program tracking of market research and patient support programs implemented for oncology drugs.
- Performed quality-verified study/program information for periodic benefit-risk evaluation reports (PBRER) and DSUR as per ICH GCP guidelines.
Drug Safety Associate
Tata Consultancy Services
Mumbai
02.2018 - 04.2020
- Performed initial evaluation/triage, duplicate search, and book-in in the database and routing cases to appropriate workflow.
- Processed serious/non-serious adverse events to ensure accurate and consistent data entry, with emphasis on timeline and quality.
- Quality Check and Analysis of patient's safety data, which is incorporated in Safety data base, as per client requirement and regulation authority.
- Coding of diseases using MedDRA and WHO-DD (WHO-drug dictionary) coding for adverse events and proper medication in accordance with the conventions of coding.
- Performed and managed the collection, documentation, triage, and processing in the safety database, transferring to global processing sites.
- Performed reconciliation of ICSRs/product complaints with appropriate internal and external stakeholders in a timely manner and in compliance with procedures.
Education
Bachelor of Pharmacy - Pharmacy
Bharati Vidyapeeth's College of Pharmacy
Mumbai06.2017
Skills
- Technical Skills: Microsoft Office & Excel, Regulatory Compliance, Data Analyst, Good Documentation Management, Argus Database, Data Validation, Software Development Life Cycle (SDLC)
- Soft Skill: Communication , Teamwork, Customer Service, Active Listening, Flexibility
Accomplishments
- Best Mentor of the Year 2022-2023: Recognized and awarded for exceptional mentoring skills, providing guidance, and support to colleagues, contributing to their professional development.
- Designed and developed a user-friendly Excel sheet to facilitate efficient data entry and management, resulting in positive outcomes, such as increased data accuracy, reduced data entry time.
English
Telugu
First Language
English
Advanced (C1)
C1
Hindi
Proficient (C2)
C2
Marathi
Advanced (C1)
C1
Hobbies and Interests
Cricket
Football
Trekking
Timeline
Data Analyst
Cognizant Technology Solutions India Private Limited
04.2023 - Current
Junior Data Analyst
04.2020 - 04.2023
Drug Safety Associate
Tata Consultancy Services
02.2018 - 04.2020
Bachelor of Pharmacy - Pharmacy
Bharati Vidyapeeth's College of Pharmacy
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