Associate Lead

1 month ago


Delhi, India Arcolab Private Limited Full time
Qualification:

MBBS/MD (only from Indian university)Experience:

2 to 4 yearsPrevious experience in medical review of ICSRs, Signal detection activity and aggregate safety reports.Knowledge of safety databases, such as Argus, ARISg, or similar systems.Familiarity with medical coding dictionaries (e.g., MedDRA) and adverse event reporting standards (e.g., ICH E2B).Strong attention to detail and ability to work with complex medical data.Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders.

Key Responsibilities:Individual Case Safety Reports (ICSRs) Review:Conduct thorough and objective medical review of ICSRs received from various sources, including clinical trials, spontaneous reports, and literature.Assess the medical relevance and causality of adverse events reported in ICSRs.Identify and evaluate potential safety signals and perform appropriate follow-up actions as necessary.Ensure accurate and timely reporting of serious and non-serious adverse events to regulatory authorities.Aggregate and Signal Reports:Review and evaluate aggregate safety reports, such as periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs), development safety update reports (DSURs), CAR, and PADERs.Review and evaluate Signal detection reports and RMPs.Ensure compliance with regulatory guidelines and reporting requirements during the review of aggregate reports.Identify any emerging safety concerns, trends, or patterns from the aggregated safety data.Collaborate with cross-functional teams to contribute to risk management activities and safety signal detection.Authoring/review of signal detection activityUtilize statistical and data mining techniques to identify trends and patterns indicative of potential safety concerns. Performing validation for potential signals.



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