Amit Shinde
Pune
Summary
Driven professional with strong leadership skills and proven track record of success. Knowledgeable in MICC (US, Canada and Europe), Clinical Trials, PMS, Audit and Inspections, ICSR Management, Pharmacovigilance, Quality and compliance, CAPA Management. Proven ability to motivate teams to achieve desired outcomes.
Overview
7
7
years of professional experience
Work History
Team Leader
Tata Consultancy Services
Pune
04.2023 - Current
- Case allocation and Workflow review / Management
- Primary Point of Contact for client and vendors
- Reconciliation of cases with Partners, Authorities and different client sites
- Preparation of Project specific document, Example - Training Plan, BCP, Quality Management Plan
- Mentoring and Training to new associates
- Query Management in Clinical Study and PM case processing
- Arrange Quality meeting with team, daily huddle with team and client meeting
- Literature search string review and maintenance
- Assessment of individual performance for appraisal and promotions
- Identify area of development for team's improvement
- End to end billing
- Review, extract, and accurately enter adverse event data from marketed product, adverse event reports received from spontaneous and/or solicited and/or clinical trial and/or legal and/or literature sources including health professionals, sales representatives, consumers, licensing partners and drug information centers in accordance with currently defined case handling procedures
- Interpret case-related information including AE coding, medical conditions, lab results and procedures etc
- As well as compile complete narrative summaries
- Process reportable and non-reportable cases within applicable timelines
- Meet specified productivity and quality targets for case handling
- Assessment, data entry and quality review of initial and/or follow-up
Drug Safety Associate
Tata Consultancy Services
Pune
02.2021 - 03.2023
- Case allocation and Workflow review / Management
- Primary Point of Contact for client and vendors
- Reconciliation of cases with Partners, Authorities and different client sites
- Preparation of Project specific document, Example - Training Plan, BCP, Quality Management Plan
- Mentoring and Training to new associates
- Query Management in Clinical Study and PM case processing
- Arrange Quality meeting with team, daily huddle with team and client meeting
- Literature search string review and maintenance
- Assessment of individual performance for appraisal and promotions
- Identify area of development for team's improvement
- End to end billing
- Review, extract, and accurately enter adverse event data from marketed product, adverse event reports received from spontaneous and/or solicited and/or clinical trial and/or legal and/or literature sources including health professionals, sales representatives, consumers, licensing partners and drug information centers in accordance with currently defined case handling procedures
- Interpret case-related information including AE coding, medical conditions, lab results and procedures etc
- As well as compile complete narrative summaries
- Process reportable and non-reportable cases within applicable timelines
- Meet specified productivity and quality targets for case handling
- Assessment, data entry and quality review of initial and/or follow-up
Junior Scientific and Medical Writer
Springer Nature Technology and Publishing Solutions
Pune
08.2019 - 01.2021
- Answer and assign calls to MICC specialist through email/fax/mail/voice mail. Access and maintain Voicemailboxes/tracking
- Attend client meeting and sharing quality updates with team
- Acting as a SME and documenting RCA CAPA
- Manage product specific inquiries/medical inquires , product complaints, AE/SAE calls as needed
- Applying regulatory and internal guidance to determine if the case meets the definition of a valid case report and Non- individual case reports.
- Evaluation of Serious Adverse Event to ensure accurate processing from source documents with emphasis on quality and timeliness.
Safety Data Analyst
Sciformix Technologies Private Limited.
Pune
05.2017 - 08.2019
- Review, assess, process and report the adverse events for solicited, spontaneous and literature cases according to applicable regulations, guidelines, SOPs and project requirements within the specified timelines by meeting the quality standards
- Ensure a duplicate check is conducted against the Global Safety Database for all ICSRs in order to determine whether there is an existing case file
- Creating an electronic case report file for a new case
- Assessment of case reports for potential important medical events, seriousness, case validation, and labeling
- Perform safety data entry in the database, coding relevant medical terminology, writing descript narratives, performing quality control and ensure case reporting
- Generating queries pertinent to the case and communicating with client for resolution before missing the internal timelines
- Coding of medical history, drugs and reported adverse event terms in safety database using medical dictionaries like MedDRA and WHODRL
- Setting up a case follow-up as per the applicable guidelines and reporting the case to the respective regulatory agencies.
Education
Bachelor of Pharmacy - Pharmacy
Indira College of Pharmacy
04.2010
Skills
- Daily Workflow Management
- Overseeing Daily Activities
- Databases - DCI, Opentext, Argus
- Issue Resolution
- ICSR Processing
- People Management
- MICC, Legal, Clinical Trial and PMS
- Audit and Inspections
- Quality and CAPA Management
- Project Financial Management
- Daily Workflow Improvement
- Medical Devices
Permanent Address
Sr no 51/2, Vivekanand nagar, Tathawade, Pune 411033
Personal Information
Date of Birth: 10/28/1992
Timeline
Team Leader
Tata Consultancy Services
04.2023 - Current
Drug Safety Associate
Tata Consultancy Services
02.2021 - 03.2023
Junior Scientific and Medical Writer
Springer Nature Technology and Publishing Solutions
08.2019 - 01.2021
Safety Data Analyst
Sciformix Technologies Private Limited.
05.2017 - 08.2019
Bachelor of Pharmacy - Pharmacy
Indira College of Pharmacy
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