Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Quote
Work Preference
Work Availability
Languages
Timeline
Hi, I’m

Bharath Subhash

Bharath Subhash

Summary

Pharmacovigilance Professional with 10 years of experience in leading pharmacovigilance and project management at Accenture. Proficient in Argus, Aris-G, and LSMV database management with knowledge of FDA, EMA, ICH, GVP, GCP guidelines. Expertise in process efficiencies, staff training, ICSR quality review, submissions, CAPA, Deviation Management, QMS, RCA and trend analysis.

Overview

11
years of professional experience
1
Certification

Work History

Accenture

Associate Manager, Pharmacovigilance
06.2021 - Current

Job overview

  • Managed adverse event case processing teams, ensuring compliance with reporting requirements.
  • Participated in the development and continuous improvement of processes and workflows, including SOPs.
  • Led Quality Governance meetings with clients to discuss quality and compliance metrics.
  • Successfully managed Oncology portfolio transition.
  • Streamlined processes for increased efficiency and cost savings within the project using RPA.
  • Developed training materials and conducted training presentations for pharmacovigilance staff.
  • Participated in User Acceptance Testing (UAT) for the NavaX system.

Accenture

Team Lead, Pharmacovigilance
10.2017 - 05.2021

Job overview

  • Led automation projects that increased efficiency and reduced dependency on personnel.
  • Analyze quality deviations, identifying root causes, adjudicating ICSR corrections with corresponding issuance of CAPA, as appropriate, to evaluate CAPA effectiveness.
  • Defined and tracked KPIs for various therapeutic areas.
  • Managed client audits and ensured timely execution of audit recommendations.
  • Evaluated team members' adverse event case reports for performance improvement.

Accenture

Pharmacovigilance Analyst
03.2016 - 09.2017

Job overview

  • Analyze ICSRs quality data of in-line QCs/ off-line QCs (e.g., correction requests).
  • Led various therapeutic area projects, ensuring adherence to client procedures.
  • Facilitated therapeutic area group meetings and documented action items.

Accenture

Pharmacovigilance Specialist
07.2014 - 02.2016

Job overview

  • Analyzed AE reports, ICSR &coding AE's using MedDRA.
  • Communicated with clients regarding case-related queries and follow-ups.
  • Trained new team members on safety data processing and project activities.

Education

Annamalai University

Master of Pharmacy
07.2013

University Overview

Skills

  • Databases: Argus, ArisG, LSMV, NavaX
  • Tools: Power BI, Excel, PowerPoint
  • Project Management
  • Prioritization & Workflow management
  • ICSR & process quality checks
  • Training and Mentoring
  • Compliance & Deviation management
  • Client-vendor communications
  • Robotic Process Automation
  • Lean Six Sigma Green Belt

Accomplishments

Accomplishments
  • Achieved ~16k $ saving by introducing batch Macro for line-listing tasks.
  • Achieved automation in LP & KPI RCA's by developing MS Excel with ~62% accuracy and efficiency.

Certification

Lean Six Sigma Green Belt

Quote

Every problem is a gift—without problems we would not grow.
Tony Robbins

Work Preference

Work Type

Full Time

Work Location

On-SiteHybrid

Important To Me

Career advancementPersonal development programs
Availability
See my work availability
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Languages

English
Bilingual or Proficient (C2)
Telugu
Advanced (C1)
Tamil
Intermediate (B1)

Timeline

Associate Manager, Pharmacovigilance
Accenture
06.2021 - Current
Team Lead, Pharmacovigilance
Accenture
10.2017 - 05.2021
Pharmacovigilance Analyst
Accenture
03.2016 - 09.2017
Pharmacovigilance Specialist
Accenture
07.2014 - 02.2016
Annamalai University
Master of Pharmacy

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Bharath Subhash