Summary
Overview
Work History
Education
Skills
Awards
Accomplishments
Interests
Timeline
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Vijaykrishnan Ganesan

Vijaykrishnan Ganesan

Director, Pharmacovigilance Safety Operations
Hyderabad

Summary

With over 18 years of experience in the pharmaceutical industry, I have expertise in Pharmacovigilance - Processing & Reporting of Individual Case Safety & Aggregate Reports, Safety Database Customizations & User Acceptance Testing/Validations, Literature Review, Business process excellence and robotic process automations, project management, patient centricity, audit and inspection readiness. As the Director of Pharmacovigilance Safety Operations at Parexel, I lead a team of Healthcare/Life science professionals in ensuring the safety and quality of clinical trials and post marketing programs. Holding an EMBA in Pharma Management from the Indian Institute of Pharmaceutical Management and a Post Graduate Program in Business Analytics and Business Intelligence from The University of Texas at Austin - Red McCombs School of Business, passionate about building First Time Quality and applying data-driven insights to improve patient outcomes and enhance operational efficiency. Additionally, enjoys sharing knowledge and skills through training, mentorship, and thought leadership forums.

Overview

18
18
years of professional experience
10
10
years of post-secondary education

Work History

Director, Pharmacovigilance Safety Operations

Parexel International India Pvt Ltd
Hyderabad
04.2021 - Current
  • Input and oversight of Regional Safety Services processes and procedures, including continuous improvement Supports the regional strategic direction and resource allocations jointly with the regional safety head in India
  • Support market and business development on behalf of the entire Safety Services organization
  • Provide regional input into Safety Services business plan, development, budgets, general and growth strategy, including global expansion
  • Act as technical expert of PV Drug Safety Services for internal and external stakeholders
  • Public representation of the Safety Services organization, including attendance and presentations at international PV conferences and symposiums

Associate Director, Pharmacovigilance Safety Operations

Parexel International India Pvt Ltd
11.2017 - 04.2021
  • Line manage and supervise regional Drug Safety staff on a day-to-day basis, guiding performance of Drug Safety staff in ongoing projects in terms of quality of deliverables and compliance with the budget, as well as providing their own technical and process-related expertise to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs)

Senior Manager, PV Safety Operations

Parexel International India Pvt Ltd
05.2015 - 10.2017
  • Project Management, Line Management, Safety Processing, Regulatory Reporting, Aggregate Reports, Literature Monitoring, Audits & Inspections

Manager, PV Safety Operations

Parexel International India Pvt Ltd
11.2012 - 04.2015
  • Line Management, Safety Processing, Regulatory Reporting, Aggregate Reports, Literature Monitoring, Audits & Inspections

Associate Manager, PV Safety Operations

Parexel International India Pvt Ltd
06.2011 - 10.2012
  • Line Management, Safety Processing, Regulatory Reporting, Literature Monitoring, Training & Mentorship, Subject Matter Expert of Safety Databases

Drug Safety Specialist, PV Safety Operations

Parexel International India Pvt Ltd
02.2010 - 04.2011
  • Safety Case Processing & Submission, Narrative Writing, Literature Monitoring, Training & Mentorship of New hires, Supporting audits & inspections

Safety Reviewer

Accenture Services Pvt Ltd
04.2007 - 02.2010
  • Developed project specific safety reporting procedures and workflows to provide guidance to the team on the procedures
  • As a Subject Matter Expert, provide project training, onboarding and mentorship for the new joiners
  • Developed customized strategies in co-ordination with Team leads and Project Managers to meet quality requirements efficiently and meet timelines set by the client

Education

Post Graduate Program - Business Analytics and Business Intelligence

The University of Texas At Austin - Red McCombs School of Business
Austin, Texas
01.2019 - 01.2020

AI & ML Blackbelt+ Certification Program -

Analytics Vidhya
Noida, India
01.2019 - 01.2020

Executive MBA - Pharma Management

Indian Institute of Pharmaceutical Management
Lucknow, India
01.2007 - 01.2009

Executive Post-Graduate Diploma - Human Resources Management

Loyola Institute of Business Administration
Chennai, India
01.2006 - 01.2007

Bachelor of Dental Surgery -

Sri Ramachandra University
Chennai, India
01.2001 - 01.2006

Skills

Awards

  • Beyond Leadership Award, Parexel, 12/24, For contributions towards India Strategic Initiatives
  • Hall of Fame, Indian Society for Clinical Research, 02/24, Recipient of Hall of Fame (HOF) Award for significant contributions towards ISCR Pharmacovigilance Council in India
  • Hall of Fame, Indian Society for Clinical Research, 02/23, Recipient of Hall of Fame (HOF) Award for significant contributions towards ISCR Pharmacovigilance Council in India

Accomplishments

Active collaboration with study teams to ensure the project deliverables are delivered within the budget and allocated hours are spent judiciously to ensure all the billable tasks are completed within the stipulated deadlines.


Helped to identify inefficiencies to remove redundancies like hand-offs, multiple QCs, checklist preparation etc. to improve overall process efficiency and promote First Time Quality (FTQ) by automating certain manual processes.


Active role in the conceptualization and implementation of Strategic Operational Data Delivery (SODD) to review and refine dashboard wireframes and data source prioritization for data lake ingestion.


Supported increase the EBITDA & profitability of the company by implementing cost-saving measures (for e.g Advance Pricing Agreement).


Passionate in exploring new revenue streams and leveraging emerging technologies like Generative AI for risk management strategies for complex drugs and rare diseases.


Interests

Books, Meditation, Hindustani Flute, Bike Riding, Swimming

Timeline

Director, Pharmacovigilance Safety Operations

Parexel International India Pvt Ltd
04.2021 - Current

Post Graduate Program - Business Analytics and Business Intelligence

The University of Texas At Austin - Red McCombs School of Business
01.2019 - 01.2020

AI & ML Blackbelt+ Certification Program -

Analytics Vidhya
01.2019 - 01.2020

Associate Director, Pharmacovigilance Safety Operations

Parexel International India Pvt Ltd
11.2017 - 04.2021

Senior Manager, PV Safety Operations

Parexel International India Pvt Ltd
05.2015 - 10.2017

Manager, PV Safety Operations

Parexel International India Pvt Ltd
11.2012 - 04.2015

Associate Manager, PV Safety Operations

Parexel International India Pvt Ltd
06.2011 - 10.2012

Drug Safety Specialist, PV Safety Operations

Parexel International India Pvt Ltd
02.2010 - 04.2011

Safety Reviewer

Accenture Services Pvt Ltd
04.2007 - 02.2010

Executive MBA - Pharma Management

Indian Institute of Pharmaceutical Management
01.2007 - 01.2009

Executive Post-Graduate Diploma - Human Resources Management

Loyola Institute of Business Administration
01.2006 - 01.2007

Bachelor of Dental Surgery -

Sri Ramachandra University
01.2001 - 01.2006
Vijaykrishnan GanesanDirector, Pharmacovigilance Safety Operations