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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...