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Saloni

PHARMACOVIGILANCE Drug Safety Specialist
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Location Mumbai
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Total Views23
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Member since30+ Days ago
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Contact Details
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Candidate Information
  • User Experience
    Experience 2 Year
  • Cost
    Hourly Rate$2
  • availability
    AvailabilityImmediate
  • work from
    Work FromAny
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    CategoryInformation Technology & Services
  • back in time
    Last Active OnMay 08, 2024
Key Skills
Microsoft office GLPGCPSOPs
Summary

Professional Experience:


PHARMACOVIGILANCE Drug Safety Specialist+ (April 2017 to August 2019)

 

 

Ø  Expertise on Clinical trial cases and Legal case processing.

 

Ø  Received and tracked information regarding potential adverse events submitted by all reporters in the form of E2B, Jaspers, CIOMS, including, healthcare professionals, plaintiffs, co-palintiffs, co-manufacturers, call centers, consumers and other company representatives accurately with in defined reporting timelines.

 

Ø  Review, assess, triage, process and reporting the adverse event reports for Investigational and Marketed products according to applicable regulations, guidelines, SOPs and project requirements within the regulatory timelines by meeting the quality standards.

 

Ø  Ensure a duplicate check is conducted against the Global safety database (SAPPHIRE) in accordance with SOPs for ICSRs (Individual case safety reports) in order to find existing case file and creating an electronic case report file for a new case.



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