Associate Lead

4 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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