Associate Lead

3 weeks ago

Bengaluru, India Arcolab Private Limited Full time
Qualification: MBBS/MD (only from Indian university)

Experience: 2 to 4 years

- Previous 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 activity- Utilize statistical and data mining techniques to identify trends and patterns indicative of potential safety concerns. Performing validation for potential signals.

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