Work from Office
Full Time
• Review ICSRs (serious and non-serious) for appropriateness of adverse event coding, seriousness, labeling, and medical content.
• Perform causality assessments and complete medical assessment comments. • Follow-up on critical cases and support Analysis of Similar Events. • Evaluate SUSAR follow-ups not reportable to FDA/Investigators. • Participate in signal detection and escalate potential safety concerns. • Medically interpret information for codification (e.g., MedDRA) in support of safety surveillance activities. • Conduct labeling activities as required.
Candidates should be MCI registerd.
Wipro
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