Vidhun PV

Address: #406 Purnima Classic, Basapura Village Road, E-city, Bangalore 560100
Phone: 9731200430
Email: pvvidhun@gmail.com
LinkedIn Profile: https://www.linkedin.com/in/vidhun-pv-795a2417/

A Seasoned, team spirited and performance-driven Pharmacovigilance Lead with hands-on experience in
Drug Safety, Literature Review and User Acceptance Testing, equipped with tools and skills to perform
well in an innovative, performance and matrix driven organization.

EXPERIENCE
22-FEB-2021 – TILL DATE
ASSOCIATE TEAM LEAD – DSS 1, BIOCLINICA
• Leading a 16-member Vaccine case processing team.
• Conducting weekly team meetings to motivate the team members, addressing their concerns,
finding solutions, plan improvements and evaluating the progress.
• Monitoring and supporting the team to create a strong work culture.
• Resolving the issues and conflicts among team members.
• Supervising the drug safety – Pharmacovigilance activities per company policy.
• Co ordinating with multiple stakeholders to meet project deliverables.
• Increasing efficiency by driving operational efficiencies.
• Forecasting the inventory and resource planning.
• Communicating with External stakeholders via call and by mail.
• Building excellent customer rapport and generating business.
• RCA review and CAPA evaluation
• Case prioritization activities

08-JUN-2015 – 18-FEB-2021
SENIOR OPERATIONS SPECIALIST, IQVIA
• Understanding of regulatory requirements and support of Global reporting rules
• Worked as a SME for triage team having hands on experience in Rheumatoid Arthritis,
Psoriasis, Psoriatic Arthritis Drugs
• Case Processing including MedDRA coding, Labelling and Causality assessment.
• Use of MedDRA and writing narratives
• CAPA trainings and Deviation Memo discussion and root cause analysis.
• Communicating with External stakeholders though call on alternative days (onsite call)
• Leading a pilot team of 8 members of UAT project.
• User Acceptance testing of database migration from Sceptre to ArisG and Argus to ArisG
(Actelion Project)
• Test Script execution in HPALM and review
• Database migration activities (Sceptre to ArisG and Argus to ArisG)
• Planning, evaluation, execution, and QC of text scripts
 JAN-2014 – JUN-2015
DSA II, NOVO NORDISK
• ICSR processing of serious and non-serious cases of anti-diabetic drugs and devices
• Acted as a point of contact for verification team
• Triage and case processing of spontaneous and clinical trial cases
• Entry of ICSR information into CCGlow
• MedDRA coding of adverse events

JAN-2012 – DEC-2013
DSA, ACCENTURE
• Data Entry of spontaneously reported adverse events (Drug and Device) including reports
from post marketing surveillance studies.
• Setting up Due diligence
• Acted as an POC for the drug safety unit team.
• Conducting sessions on client feedback and thus by contributing the quality improvement plan.

SEP-2011 – DEC-2012
RESEARCH ACCOCIATE, MMSH CLINICAL RESEARCH
• Medical writing
• QC check of narratives

APR-2011 – SEP-2011
CRC, CLINOVA
• Assisting the investigator
• Informed consent
• CRF and TMF updating
• IP Accountability

EDUCATION
2015
EX MBA (OPERATIONS MANAGEMENT), KARNATAKA STATE OPEN UNIVERSITY.

2011
PGDCR & PV, CLINIMINDS.

2010
B PHARM, PONDICHERRY UNIVERSITY.

SKILLS
 Drug Safety (Pharmacovigilance)  Workflow Management
 User Acceptance Testing and test script writing  Safety databases (Argus, ArisG, Sceptre)
 Regulatory requirements  Stakeholder management
 Good Pharmacovigilance Practice (GVP)  ICH-GCP

2
TERAPEUTIC AREAS EXPERTISE
 Immunology
 Oncology
 Covid Vaccine
 Diabetes

PERSONAL STRENGTHS
 Pro Active and Smart
 Excellent Communication skills
 Good Planner in organizing tasks
 Diligent and capable of multi-tasking

REWARDS AND RECOGINTION

• Appreciation from the Higher management for fixing workflow backlogs.
• Applause from client for the excellent work in UAT team for 2 different projects
• Numero-Uno from Previous Organization

PERSONAL INFO
DOB: 01-APR-1989
Gender: Male
Nationality: Indian
Status: Married

DECLARATION
I hereby declare that the information given above is authentic to the best of my knowledge & if given an
opportunity to work in your organization, I will put my best efforts

17-Apr-2022
Bangalore Vidhun PV