Summary
Overview
Work History
Education
Skills
Strengths
Certification
Publications
Disclaimer
Timeline
Generic

Sagar Nemade

Data Analyst
Vasai

Summary

Experienced healthcare professional skilled in Pharmacovigilance and compliance with overall 7 years in the field, skilled in drug safety systems like ARGUS and ARISg. Ability in overseeing compliance and mentoring, which enhances operational efficiency and ensures regulatory alignment. Conducting quality reviews, offering expertise to drive improvements in drug safety processes.

Overview

7
7
years of professional experience
10
10
years of post-secondary education
2
2
Certifications

Work History

PV Operations Compliance Specialist

Cognizant Technology Solutions (CTS)
11.2021 - Current
  • Currently working as a PV Operations Compliance Specialist, responsible for overseeing compliance for inward and onward submissions, including late case management activities. This involves ensuring all submissions are timely, which helps maintain regulatory alignment and avoid penalties.
  • Proficient in using PV Reporting and PV Central to monitor, track, and manage late case submissions, ensuring timely follow-up, escalation, and resolution of compliance risks.
  • Conduct compliance reviews of pharmacovigilance activities, documentation, and processes to ensure alignment with global regulatory requirements. This ensures that all safety data is handled according to industry standards, preventing compliance issues.
  • Experienced in ARGUS Safety Database and PVI (Intake Application) for case intake, processing, and data management, which facilitates accurate and efficient handling of safety data.
  • Perform quality review of ICSRs, including Clinical Trial, Post-Marketing Surveillance, Spontaneous, and Literature cases, ensuring data integrity and compliance with regulatory standards.
  • Skilled in Partner E2B and Non-E2B case processing, which supports seamless data exchange and compliance with international safety reporting requirements.
  • Strong knowledge of medical coding using MedDRA and WHO-DD for conditions, procedures, indications, and lab tests, which ensures accurate classification and reporting of safety information.
  • Serve as a Technical Trainer and Mentor, delivering structured training sessions on PV systems, case processing standards, and regulatory compliance, which enhances team knowledge and adherence to protocols.
  • Guide and mentor new associates and junior team members on end-to-end ICSR processing, quality expectations, and system navigation, fostering a collaborative and supportive work environment.
  • Provide ongoing coaching, resolve process-related queries, and deliver regular quality feedback to support continuous improvement and operational excellence.
  • Contributed to the preparation and review of ARGUS Safety Database Manuals and internal SOPs, which ensures comprehensive documentation and adherence to best practices.

Pharmacovigilance Scientist Level II

Tata Consultancy Services (TCS)
02.2018 - 10.2021
  • Experienced in ARISg safety database (version 6.0, 6.3, 6.4) and Ag-Xchange, which facilitated efficient case management and compliance with regulatory standards.
  • Processed and reviewed complex and SUSARS cases, ensuring accurate data capture and timely reporting, which mitigated potential compliance risks.
  • Handled Labelling /Medical assessment of the SAE reports and ensured safety data was reported within regulatory timelines, which maintained alignment with client expectations and legal requirements.
  • Performed accurate data capture for ICSRs and summary reports, which included spontaneous, clinical, NIS, and NIP origins, ensuring comprehensive safety monitoring.
  • Assessed the causal relationship and appropriate clinical assessment of seriousness and company causality of identified adverse events, adhering to SOPs/company-controlled documents and regulatory requirements.
  • Conducted narrative writing and case processing as recommended by USFDA in compliance with 21CFR11, following Good Pharmacovigilance Practices, ensuring high-quality documentation.
  • Good knowledge of coding of medical history, drugs, and adverse event terms using WHO drug dictionary and MedDRA (Version 21.0), ensuring proper coding into the safety database.
  • Performed case deletion from safety database by determining whether a case should be nullified or if a follow-up report should be deleted, ensuring data accuracy and integrity.
  • Knowledgeable about EU Clinical Trials directive and EMA centralization, which supported regulatory compliance and informed decision-making.
  • Served as a Case Processing Mentor, conducting training for new associates, which helped integrate them into the team and ensured consistent application of best practices.

Education

Quality Assurance -

MET 's Institute of Pharmacy
Nashik
07.2015 - 06.2017

Pharmacy -

HLMC TVES Collage of Pharmacy
Faizpur
07.2011 - 06.2015

Science -

New English School Junior College
Vasai
07.2009 - 06.2011

General Education -

Holy Cross High School
Vasai
07.2007 - 06.2009

Skills

  • ARGUS Safety Database

  • ARISg safety database

  • PV intake application

  • PV reports/central application

  • Pharmacovigilance compliance

  • Regulatory submissions overview

  • Medical coding (MedDRA, WHO-DD)

  • Technical Trainer

  • Case processing mentor

Strengths

  • Effective communication
  • Problem solving
  • Leadership in team settings
  • Continuous learning

Certification

Certified Pharmacovigilance Professional, PharmaCert

Publications

Development of nanoemulsion of antiviral drug for brain targeting in the treatment of neuro-AIDS, Beni-Suef Univ J Basic Appl Sci, 

06/2022, 

Nemade, S.M., Kakad, S.P., Kshirsagar, S.J. et al. Development of nanoemulsion of antiviral drug for brain targeting in the treatment of neuro-AIDS. Beni-Suef Univ J Basic Appl Sci 11, 138 (2022).

Disclaimer

I hereby declare that the above-mentioned information is correct, and I bear the responsibility for the correctness of the above-mentioned particulars.

Timeline

PV Operations Compliance Specialist

Cognizant Technology Solutions (CTS)
11.2021 - Current

Certified Pharmacovigilance Professional, PharmaCert

05-2020

Pharmacovigilance Scientist Level II

Tata Consultancy Services (TCS)
02.2018 - 10.2021

Quality Assurance -

MET 's Institute of Pharmacy
07.2015 - 06.2017

Pharmacy -

HLMC TVES Collage of Pharmacy
07.2011 - 06.2015

Science -

New English School Junior College
07.2009 - 06.2011

General Education -

Holy Cross High School
07.2007 - 06.2009

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Sagar NemadeData Analyst