Open to opportunities

Balesh Tandle

@baleshtandle

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Experienced pharmacovigilance manager and medical reviewer ensuring drug safety compliance.

India

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What I'm looking for

I seek a pharmacovigilance or drug-safety role where I can lead safety assessments, improve signal management, ensure regulatory compliance, and mentor teams in a collaborative, quality-driven environment.

I am a Pharmacovigilance Specialist and Medical Reviewer with hands-on experience assessing Individual Case Safety Reports (ICSRs), compiling PADERs, contributing to PSURs, and evaluating PBRERs to support regulatory submissions and patient safety.

As a Manager at Amneal Pharmaceuticals, I led signal detection, assisted Risk Management Plan development, performed literature case processing, and executed rigorous quality reviews and SOP management to maintain compliance and drive process improvements.

My background as a practicing physician and medical officer informs my clinical assessments and risk evaluations; I deliver pragmatic safety recommendations, mentor cross-functional teams, and strive for proactive risk minimization and continuous improvement.

Experience

Work history, roles, and key accomplishments

Current

Manager - Medical Reviewer

Current

Amneal Pharmaceuticals

Jun 2023 - Present (2 years 3 months)

Manage medical review and pharmacovigilance activities including ICSR assessment, PADER/PBRER/PSUR contributions, signal detection, and RMP support to ensure regulatory compliance and patient safety.

ICSR Assessment PADERs PBRER)PSURs Signal Detection SOPs

Factory Medical Officer

Sequent Scientific

Sep 2021 - Jun 2023 (1 year 9 months)

Provided on-site occupational health services including pre-employment and periodic medical examinations, emergency care, health surveillance, and training to maintain workforce health and regulatory compliance.

Occupational Health Emergency Response PPE Training Medical Records Compliance

Doctor (Self Employed)

Self Employed

Jun 2019 - Sep 2021 (2 years 3 months)

Delivered comprehensive clinical care, diagnosis and treatment, preventive health education, and maintained GCP-compliant medical records while managing acute and chronic conditions.

Patient Management Preventive Health GCP)Patient Education Chronic Disease Management

Medical Officer

Indiabulls Foundation

Feb 2019 - Jun 2019 (4 months)

Provided primary healthcare via a mobile medical van to rural communities, delivering consultations, treatments, health education, and managing medical supplies and documentation.

Primary Care Health Education GCP)Community Outreach Medical Documentation Emergency Care

Medical Officer

Government of Maharashtra

Jan 2017 - Jan 2018 (1 year)

Managed diagnosis, treatment, preventive care and community health programs in resource-constrained settings, and led emergency stabilization and public health initiatives.

Clinical Care Preventive Health Emergency management Community Health Patient Education Public Health