KV

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Kishma Vinod

@kishmavinod1

Senior Clinical Research & Pharmacovigilance Manager at Bharat Serums & Vaccines Ltd., delivering global trial and regulatory submissions.

At Bharat Serums & Vaccines Ltd., I lead Phase I–IV global clinical trials, including COVID-19, critical care, and women’s health studies. I’ve also led real-world evidence studies and publication strategy.

I’ve prepared regulatory documents across Asia, Europe, and Africa, and delivered CTD Modules 2–5, PSURs, PBRERs, and RMPs. My work includes protocol development, scientific manuscripts, and applying data science and analytics to clinical decision-making.

Experience

Work history, roles, and key accomplishments

BL

Current

Senior Manager – Clinical Research & PV

Current

Bharat Serums & Vaccines Ltd.

Jan 2010 - Present (16 years 10 months)

Lead global clinical trials (Phase I–IV) including COVID-19, Critical Care, and Women's Health studies. Directed preparation of regulatory documents and delivered CTD Modules, PSUR, PBRER, and RMP for key products.

Clinical Research Pharmacovigilance Regulatory Strategy CTD PSURs PBRERs RMP Real World Evidence Medical Writing Publication Strategy

SC

Clinical Assistant

Surya Neuro Center

Jan 2000 - Dec 2010 (10 years 11 months)

Engaged in clinical practice, neurology trials, and patient management.

Clinical Practice Neuroscience Clinical Trials Patient Management

Education

Degrees, certifications, and relevant coursework

DU

Deakin University

Master's, Data Science

Pursued a Master's in Data Science, completing in 2025.

TM

Texas McCombs

PG Program, Data Science & Business Analytics

2023 - 2024

Completed a PG Program in Data Science & Business Analytics from 2023 to 2024.

MU

Mumbai University

BHMS, Homeopathy

Earned a BHMS degree from Mumbai University.

Tech stack

Software and tools used professionally

Tableau

SAS

Python

Azure

Availability

Looking for a job

Location

India

Authorized to work in

Salary expectations

3020k+ INR

Social media

Job categories

Clinical Research and Pharmacovigilance Manager Pharmacovigilance Manager

Skills

Clinical Research Clinical Trial Management Phase I IV Clinical Trials Protocol Development Medical Writing Regulatory Strategy Global Regulatory Submissions CTD ACTD Pharmacovigilance Risk Management PSURs PBRERs RMP Real World Evidence

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