Profile Details

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Hire Hitasha B.

India

USD 12 /hr

Pharmacovigilance and Clinical Research Professional with more than 12 years of experience.

Profile Summary

I am a pharmacy post graduate with specialization in pharmacology from University of Delhi with more than 12 years of experience in the pharmaceutical industry, clinical research, and pharmacovigilance. I have consistently delivered projects across various pharmacovigilance domains that include case processing, aggregate reports, and literature surveillance along with e-tool for literature search & AI tools for case processing. I have an added experience in development of online tools for clinical researchers in development sector. I've lead a team of experts in aggregate report preparation, and has also worked on the development and validation of various tools to automate clinical trial processes like ethics committee approvals, etc. I have trained various ethics committees on the developed tools across India. I have worked on pre and post-marketing safety monitoring of a wide portfolio of drugs like antivirals, anti-malarials, immunotherapeutics, etc.

Subject Matter Expertise

• ★ Pharmacovigilance/Drug Safety Monitoring
• ★ Medical Writing
• ☆ Surveillance Systems
• ☆ Clinical Trials
• ☆ PreMarket Approval (PMA) Applications

Services

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review, Secondary Data Collection

Work Experience

Self Employed

Consultancy & Freelancing

January 2020 - Present

SENIOR CONSULTANT- PHARMACOVIGILANCE

Soterius Inc.

February 2019 - December 2019

CONSULTANT- CLINICAL RESEARCH & PHARMACOVIGILANCE

PATH

January 2017 - January 2019

CONSULTANCY AND FREE LANCING

Self employed

August 2014 - December 2016

Senior Executive Pharmacovigilance

Panacea Biotec Limited

July 2011 - July 2014

Team Leader Pharmacovigilance

APCER Pharma India Ltd.

November 2008 - March 2011

Education

MASTERS IN PHARMACY (PHARMACOLOGY)

University of Delhi

July 2006 - June 2008

BACHELORS IN PHARMACY

University of Delhi

July 2002 - June 2006

Certifications

• Certification details not provided.