Manisha (Isha) Arora - Associate Director, IQVIA

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Network Power100+ people

Roles

🔥41%

Startup Founder

🧨34%

Consulting

✔️33%

Geos

🇮🇳54%

India

🇺🇸9%

United States

🇦🇪6%

United Arab Emirates

Work Background

IQVIAEngagement Manager ( Associate Director)

Jul. 2017Noida

HighPoint SolutionsManager Consulting Services

Aug. 2016 - Jul. 2017Noida

November Research GroupSr Consultant

Aug. 2009 - Jul. 2012Colorado Springs, Colorado, United States

Relsys India Pvt LtdApplication Consultant

Sep. 2007 - Apr. 2009

Dr. Reddy's LaboratoriesAssistant Manager

Aug. 2006 - Oct. 2007Setting up the Global Pharmacovigilance Center in the Organization. Have worked towards implementing, validating for ARISg5 database. Have complete ownership of assigned AE cases. Oversee the local clinical assessment and approval for all individual adverse reactions, and/or serious individual adverse events collected from appropriate solicited sources. Facilitate safety data analysis and management by optimizing the quality documentations and assessment of individual reports from certain clinical studies and all post-marketing events. Ensure compliance with Dr Reddys’ SOPs related to the collections, evaluation, analysis, and reporting of adverse experience reports. Provide oversight, training and coaching for members for the Case Management Team involved in the collection, processing, assessment and storage of adverse event reports. Contribute to the preparation and the review of Periodic Safety Update Reports, as needed