Safety Aggregate Report Spec 1

2 days ago

Bengaluru Hyderabad Kolkata, India IQVIA Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Project role : Safety Aggreg Report Spec 1

Work experiences : 2 to 6 years.

Work location : Hybrid

Must have skills : "Aggregate Report", PBRER, PSUR, DSUR, PADER, "Signal Management", "Signal Detection"

Essential Functions :

Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings

3 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance

Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. Conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks

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