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Ashwin Kelwalkar Email & Phone Number

Manager, Global PhV Compliance at Incyte
Location: Downingtown, Pennsylvania, United States 10 work roles 2 schools
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Current company
Role
Manager, Global PhV Compliance
Location
Downingtown, Pennsylvania, United States
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Who is Ashwin Kelwalkar? Overview

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Ashwin Kelwalkar is listed as Manager, Global PhV Compliance at Incyte, a with 1767 employees, based in Downingtown, Pennsylvania, United States. AeroLeads shows a matched LinkedIn profile for Ashwin Kelwalkar.

Ashwin Kelwalkar previously worked as Manager, Global Pharmacovigilance Operations at Incyte and Manager, GPSM, Pharmacovigilance at Incyte. Ashwin Kelwalkar holds Master’S Degree, Pharmacy Administration from St. John'S University.

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Incyte

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About Ashwin Kelwalkar

Ashwin Kelwalkar is a Manager, Global PhV Compliance at Incyte. He is proficient in English, Hindi and Marathi.

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Incyte
Incyte
Manager, Global PhV Compliance
wilmington, delaware, united states
Website
Employees
1767
AeroLeads page
10 roles

Ashwin Kelwalkar work experience

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Manager, Global Phv Compliance

Downingtown, Pa, Us

Manager, Global Pharmacovigilance Operations

Manager, Gpsm, Pharmacovigilance

Wilmington, Delaware, United States

Responsible for overseeing Global Pharmacovigilance (PhV) business support activities and supporting other GPSM Project deliverables. Responsible for ensuring PhV business project support for the safety document distribution management system, business project support for Incyte programs (e.g. IST/IIRs, Market research/Access programs), reconciliations, and reporting requirements for various global team initiatives within GPSM. Streamline collaboration with multiple Incyte departments as applicable, by guiding PhV activities for all Incyte compoundsEssential Functions of the Job: Provide functional GPRM leadership over Clinical trial and Post-marketing, Business Support related Pharmacovigilance processes. Support GRMSS, GPRM, and the EU-QPPV as required.Provide in-depth technical experience on Pharmacovigilance general processes and systems.Departmental support for Business Support overview, including during Audits and Inspections.Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.Support GPRM efforts for new NDA/MAA regulatory tasks, as required. Facilitate new GPSM projects requiring cross-department training and brainstorming sessions for management and set-up of support systems and processes, as required. Act as Subject Matter Expert (SME) with Business partners, PhV service providers and other vendors.Support Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources), as required.Lead strategic GPSM project(s) and actively support GPSM Business Support Leads with assigned projects.Ensure compliance with internal procedures, regulatory requirements, and business partner agreements to ensure inspection readiness at all times.

Feb 2023 - Sep 2023

Sr Lead, Business Support, Gpsm, Pharmacovigilance

Wilmington, Delaware, United States

Feb 2021 - Feb 2023

Senior Drug Safety Associate

Incyte

Wilmington, Delaware

Feb 2018 - Feb 2021

Drug Safety Associate

Wilmington, Delaware

Aug 2015 - Feb 2018

Patient Safety Specialist

Wilmington, Delaware

Apr 2013 - Aug 2013

Associate, Operation Specialist

Parsippany, New Jersey

Mar 2011 - Mar 2013
Team & coworkers

Colleagues at Incyte

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2 education records

Ashwin Kelwalkar education

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What company does Ashwin Kelwalkar work for?

Ashwin Kelwalkar works for Incyte.

What is Ashwin Kelwalkar's role at Incyte?

Ashwin Kelwalkar is listed as Manager, Global PhV Compliance at Incyte.

Where is Ashwin Kelwalkar based?

Ashwin Kelwalkar is based in Downingtown, Pennsylvania, United States while working with Incyte.

What companies has Ashwin Kelwalkar worked for?

Ashwin Kelwalkar has worked for Incyte, Biomarin Pharmaceutical Inc., Astrazeneca, Iqvia, and Tata Consultancy Services.

Who are Ashwin Kelwalkar's colleagues at Incyte?

Ashwin Kelwalkar's colleagues at Incyte include Cory Smith, Sonia Ioannidis, Yvonne Lo, Doriane Bernard, and Yan Chun (Jason) Yeoh.

How can I contact Ashwin Kelwalkar?

You can use AeroLeads to view verified contact signals for Ashwin Kelwalkar at Incyte, including work email, phone, and LinkedIn data when available.

What schools did Ashwin Kelwalkar attend?

Ashwin Kelwalkar holds Master’S Degree, Pharmacy Administration from St. John'S University.

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