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Patient Safety Associate I

Company

Parexel

Location

Hyderabad, Telangana

Type

Full-time

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Job Summary:


We are seeking a detail-oriented Patient Safety Associate to support pharmacovigilance and drug safety operations across clinical trials and post-marketing activities. The role involves processing safety data, ensuring regulatory compliance, and contributing to high-quality safety reporting in accordance with global regulations and standard operating procedures (SOPs).

Key Responsibilities:

  • Process Individual Case Safety Reports (ICSRs) from various sources, including data entry, coding (Medical Dictionary for Regulatory Activities [MedDRA]), narrative writing, and quality checks.
  • Perform literature searches and reviews to identify potential adverse drug reactions and safety signals.
  • Support safety submissions to regulatory authorities, ethics committees, and other stakeholders within required timelines.
  • Assist in signal d...

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