Vinod Kumar

Pharmacovigilance/Drug Safety/Clinical Research professional with 14+ years of experience in the pharmaceutical industry. Proven ability to manage and oversee all aspects of pharmacovigilance activities, including case intake, triage, data entry, quality assessment, medical review, and follow-up activities. Expertise in regulatory compliance and global pharmacovigilance requirements.

Strong analytical and problem-solving skills, with the ability to work independently and as part of a team. Seeking a challenging position for any role/responsibilities in a fast-paced environment where I can use my skills and experience to make a significant contribution to the safety of patients.

• More than 14 years of Pharmacovigilance case processing and operations management expertise
• Domain expertise in managing Pharmacovigilance supportive activities like Adverse Event Mailbox

Management, Pharmacovigilance Intake, Eudravigilance tasks, Literature Assessment, Medical Literature Monitoring, Lot Validation, Product Quality Complaint queries, Business Partner Liaison activities, Legal case pre-scan and Pharmacovigilance agreement activities.

• Planned and executed multiple start up activities, training initiatives, transitions, and database migration.
• Planned and managed multiple bolus like poison control cases, legal cases, line listings and cases accumulated during transition.
• Actively participated and managed multiple audits (internal, customer, health authority) and inspections
• Actively involved in planning and execution of multiple Business Continuity and disaster recovery plans including Ransomware attack
• Lead multiple project level automotive initiatives like Workload Management tool, field v/s narrative comparison tool, reconciliation tool, project dashboards, productivity tool, quality tool, inline metrics, final review feedback notification, Laboratory details auto narrative.
• Initiated and provided inputs in developing project level bots like document comparison and auto narrative bot.
• Initiated and provided inputs in drafting client SOPs, streamlining multiple process like Intake management and Literature assessment.

Master Of Science

Bangalore University [ 2005 – 2007 ]

City: Bengaluru | Country: India

Bachelor Of Science

Bangalore University [ 2002 – 2005 ]

City: Bengaluru | Country: India