Summary
Overview
Work History
Education
Skills
Languages
Personal Information
Disclaimer
Timeline
Generic

Vignesh Vinomohan

9/5, First North Street, Kennedy Square, Perambur Chennai

Summary

Regulatory Safety Submissions and Pharmacovigilance Operations Specialist with 11 years of experience. Expertise in Line Management, Regulatory Compliance, and Data Analysis, with proven skills in preparing and presenting reports. Proficient in Argus, Safety Reporting System (SRS), e-TMF (Electronic Trial Master File), Veeva Vault, Clinical Trial Management System (CTMS), and Electronic Data Capture (EDC) systems. Committed to contributing to organizational success in a collaborative environment.

Overview

12
12
years of professional experience

Work History

Senior Pharmacovigilance Reporting Associate- Functional Lead

ICON
Chennai
05.2024 - Current
  • Responsible for project setup, maintenance, and closeout for safety reporting activities.
  • Peer review the packages prepared by the safety reporting associate, and complete the safety submission.
  • Ensure the safety reports are submitted to the required recipients within the specified timeline.
  • Review the project budget, and share input or comments with the Project Manager and Contact Analyst.
  • To provide a monthly compliance report and compliance metrics to the client, along with the RCA for all the late cases during that period.
  • To train team members on various project scenarios, key points, and updates regularly.
  • Responsible for addressing the queries raised by the client, the Regulatory Authority, and the internal teams or vendors.
  • Hands-on experience in FDA, EMA, MHRA, MFDS, and PMDA safety submissions.

Team Leader- Workflow Manager

Cognizant
Coimbatore
09.2021 - 05.2024
  • Responsible for the line management of individuals within the team, as well as the project team.
  • Manage direct reports to ensure that staff training records are up to date.
  • Responsible for managing performance reviews and issues of direct reports.
  • General oversight for the receipt and processing of all adverse event reports, reported either spontaneously from any sources, or from a clinical trial.
  • Responsible for completing and submitting all the received items as per the timelines agreed upon in the Safety Management Plan (SMP).
  • Provide reasons to the client for the previous day's spillover cases by categorizing them as IC, OOC, or OOS in the email as well as in the meeting.
  • Redeploy resources to ad hoc or other activities whenever the case volume is low; arrange support/back-up for sixth-day work and during public holidays, as per business requirements.
  • Attend the monthly governance call to provide the status of defaulters in KPI metrics and the action taken for improvement to the Delivery Manager and senior management.
  • Responsible for the weekly and monthly RCA preparation and review for prioritization miss cases and late submission cases to Regulatory Authorities.
  • Provide CAPA evidence to the client as needed.

Drug Safety Associate- Functional Lead

ICON
Chennai
09.2018 - 09.2021
  • Project setup, maintenance, and closeout for safety reporting activities.
  • Connect with the Regulatory Intelligence team to understand local regulations for submitting final packages to CA, EC, and Sites.
  • Prepared packages for SUSAR, SESAR, SAE, line listing, and periodic reports (DSUR, PSUR, 3MLL, 6MLL).
  • Performed submission according to the distribution checklist. If a delivery failure is received, the report needs to be resubmitted for those recipients via backup submission methods.
  • The new recipients and deactivated recipients need to be updated as needed in the system, based on the Clinical Operations report.
  • Ensure that the reports are submitted to the required recipients within the specified timeline.
  • Responsible for tracking the submission in the compliance tracker, and filing e-TMF.
  • Overseeing project financial health with timely invoicing and unit tracking.
  • Managed different client audits without any findings for the department.
  • Hands-on experience in CESP, MHRA, Eudralink, PMDA, and MFDS reporting.

Senior Drug Safety Associate- Subject Matter Expert

Accenture
Chennai
10.2013 - 08.2018
  • Review, assess, triage, process, and report the adverse event reports according to applicable regulations, guidelines, SOPs, and project requirements within the specified timelines by meeting the quality standards.
  • Assess adverse event reports for seriousness, causality, and expectedness, as per the Investigator Brochure, Basic Prescribing Information, or US package insert, consulting the Medical Safety Expert whenever needed.
  • Perform safety data entry in the database, coding relevant medical terminology using MedDRA, writing descriptive narratives, generating queries pertinent to the case, performing quality control, and ensuring case reporting.
  • Attend project team meetings and client calls related to the project, and provide feedback to the operations manager on any challenges or issues. Responsible for escalating the issues or tasks outside the normal scope of work.
  • Evaluation and QC of Serious Adverse Events / Post-Marketing Adverse Events to ensure accurate and consistent data entry and processing from source documents, with emphasis on timeliness and quality.
  • Training coordinator for new colleagues. Evaluation and QC of Serious Adverse Events / Post-Marketing Adverse Events to ensure accurate and consistent data entry and processing from source documents, with emphasis on timeliness and quality.

Education

Master of Pharmacy (M.Pharm) -

Mohamed Sathak A J College Of Pharmacy
Chennai, Tamil Nadu
10-2024

Bachelor of Pharmacy (B.Pharm) -

Vels University
Chennai, Tamil Nadu
07.2013

Skills

  • Adverse event reporting
  • Safety data analysis
  • Project management
  • Regulatory compliance
  • Employee training
  • Cross-functional coordination
  • Vendor management
  • Crisis management
  • Change management
  • Workflow optimization
  • Teamwork and collaboration

Languages

  • English
  • Tamil

Personal Information

  • Date of Birth: 26-Nov-1991
  • Gender: Male
  • Marital Status: Married

Disclaimer

I hereby declare that all the above information is true to the best of my knowledge and I bear the responsibility for the particulars.

Timeline

Senior Pharmacovigilance Reporting Associate- Functional Lead

ICON
05.2024 - Current

Team Leader- Workflow Manager

Cognizant
09.2021 - 05.2024

Drug Safety Associate- Functional Lead

ICON
09.2018 - 09.2021

Senior Drug Safety Associate- Subject Matter Expert

Accenture
10.2013 - 08.2018

Master of Pharmacy (M.Pharm) -

Mohamed Sathak A J College Of Pharmacy

Bachelor of Pharmacy (B.Pharm) -

Vels University

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Vignesh Vinomohan