• Works in conjunction with the Clinical Safety and Risk Management (CSRM) team in the safety surveillance of assigned products. Performs data retrieval and preliminary analysis for responses to inquiries from health professionals, regulatory agencies and other customers regarding adverse experiences reported. Providing safety inputs for aggregate reporting including but not limited to PBRER/PSURs. Signal assessment and management (Issue work-up, Assessment reports, Signal evaluation reports). Assists the CSRM team to author regulatory documents and strategizes recommending appropriate data to respond to queries (RTQs) and analyze data.

• Signal detection activities including Literature triage, Case Listing analysis, Data mining in FAERS, Eudravigilance, and Trending analysis.• Reviewed listings (SUR, Fatal etc.) and literature for new safety signal or increase in the frequency of known risks, written short assessment reports for safety issues.

• Expertise in end-to-end report writing and preparation of Aggregate reports including Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs).• Medical review of clinical trial data including SAEs, AESIs and dose limiting toxicities and issuing relevant queries on unclear, missing, or discrepant data or information.

• Expertise in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies and solicited programs), which includes Triage of ICSRs, managing duplicate couples/cases appropriately, coding of ICSRs in the safety database, writing case summaries, assessing causalities if required and writing CIOMS comments if required.