Shipra Sharma Email & Phone Number
@premier-research.com
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Who is Shipra Sharma? Overview
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Shipra Sharma is listed as Site Activation Manager at IQVIA, based in Greater Vancouver Metropolitan Area, Canada, Canada. AeroLeads shows a work email signal at premier-research.com and a matched LinkedIn profile for Shipra Sharma.
Shipra Sharma previously worked as Study Startup & Regulatory affairs Expert at Premier Research and Regulatory Consultant/ Assistant Manager at Mankind Pharma Ltd. Shipra Sharma holds Master Of Pharmacy, Pharmacology from Maharishi Markandeshwar University, Mullana.
Email format at IQVIA
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AeroLeads found 1 current-domain work email signal for Shipra Sharma. Compare company email patterns before reaching out.
About Shipra Sharma
I am strongly reliable & focused Regulatory Affairs Specialist with Strategic thinking skills with 8.5 Years of Experience in Clinical & Preclinical Research. Have Expert knowledge of relevant regulations e.g. ICH/OECD/GCP/GLP/FDA /EU guidelines. Effective independent contributor with excellent judgement and decision-making Skills. Thorough understanding of GCP, ICH Guidelines and Country regulatory environment. In depth knowledge and understanding of clinical research processes, regulations and methodology.
Listed skills include Regulatory Affairs, Clinical Trials, Microsoft Excel, English, and 43 others.
Shipra Sharma's current company
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Shipra Sharma work experience
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Site Activation Manager
Current
Study Startup & Regulatory Affairs Expert
- Preparing Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents
- Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required, including ongoing submissions, amendments.
- Proactively forecasts submission/approval timelines and ensures they are adhered to and provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified
- Performs essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
Regulatory Consultant/ Assistant Manager
Senior Tda (New Drug Division)
> Review, Process and regulate New Drug Applications/file. > Review, Process and regulate Clinical Trail queries and requests. > Review and Prepare and Clinical Study Reports (CSR) and other supporting documents.> Scrutiny of New drug, Domestic clinical trail protocol, clinical trail report, BE report and IND applications dossier as per the checklist of.
Senior Tda (Global Clinical Trial Division)
- Review protocols, IB’s, CRF’s, SAP’s, tables/listings, statistical reports, study reports. Review of Clinical Trial protocols, IB, Inclusion Exclusion Criteria.
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.
- Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of.
- Responsible for inspection of investigational sites for clinical studies in phases I-IV.
Senior Tda (Serious Adverse Event:- Injury & Death)
> Handling of SAE-Death and Injury reports that are reported to regulatory authority within the stipulated timelines. > Causality assessment of the events & its relatedness to the investigation product/Clinical Trial.> Verification of the Information/ documents submitted by Sponsor, Investigator and Ethic Committee & make sure that the submission of.
Senior Pharmacologist
Research Scientist
> In Vivo and Safety Pharmacology, Drug Safety Evaluation Carrying out various Efficacy studies, 4-Day, 14-Day & 28 Days toxicology studies, GPMT testing, Pyrogen Testing in accordance with OECD guidelines.> Supporting team in Genotoxicity & risk management.> Supporting team planning & conduct of pre-clinical studies, preparation of study reports & timely.
In Vivo Pharmacologist
Shipra Sharma education
Master Of Pharmacy, Pharmacology
Bachelor Of Pharmacy (B.Pharm.), Pharmacy, First
Twelth Grade, Science, First
Frequently asked questions about Shipra Sharma
Quick answers generated from the profile data available on this page.
What company does Shipra Sharma work for?
Shipra Sharma works for IQVIA.
What is Shipra Sharma's role at IQVIA?
Shipra Sharma is listed as Site Activation Manager at IQVIA.
What is Shipra Sharma's email address?
AeroLeads has found 1 work email signal at @premier-research.com for Shipra Sharma at IQVIA.
Where is Shipra Sharma based?
Shipra Sharma is based in Greater Vancouver Metropolitan Area, Canada, Canada while working with IQVIA.
What companies has Shipra Sharma worked for?
Shipra Sharma has worked for Iqvia, Premier Research, Mankind Pharma Ltd, Central Drugs Standard Control Organization, and Ministry Of Health & Family Welfare, Government Of India.
How can I contact Shipra Sharma?
You can use AeroLeads to view verified contact signals for Shipra Sharma at IQVIA, including work email, phone, and LinkedIn data when available.
What schools did Shipra Sharma attend?
Shipra Sharma holds Master Of Pharmacy, Pharmacology from Maharishi Markandeshwar University, Mullana.
What skills is Shipra Sharma known for?
Shipra Sharma is listed with skills including Regulatory Affairs, Clinical Trials, Microsoft Excel, English, Research, Microsoft Office, Microsoft Word, and Customer Service.
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