Associate Direc. Patient Safety Scientist

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Perform core signal detection activities and elevate program or portfolio issues impacting key Safety Management Team (SMT) programs, priorities, resources, and milestones. Draft the early safety strategy plan, the Early Development Safety Roadmap (EDSR). Author safety data query responses, author and contribute to specific PV sections of the Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR), and health authority (HA) submission documents for new and expanded indications (Filing Activities). Ensure pharmacovigilance regulatory compliance. Lead Safety Data Review (SDR) Teams in the review and evaluation of clinical data to support signal detection. Specially, this position will perform the following duties:

• Lead signal detection activities for a product’s emerging safety profile.
• Provide strong medical writing support for PV sections of safety aggregate reports (eg, DSUR, PBRER) and analyze data for the RSI section of the IB.  Collaborate with MSAP to author and analyze data for ad hoc responses to health authorities.
• Contribute to the development of the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Documents signal assessment in a Signal Report drafting a preliminary conclusion.
• Develop strategies for safety data collection in clinical trials to further characterize adverse events of interest.
• Analyze data and prepares documentation to support label updates for assigned products.
• Support the European Union Qualified Person for Pharmacovigilance (EU QPPV) or other regional or local Qualified Person for safety issues relating to assigned products.
• Collaborate with the Pharmacovigilance Centre of Excellence (PVCoE) to develop report requirements and other customized safety data visualizations.
• Serve as liaison to Medical teams for AIMS (Asset/Indication Medical Strategy), publications, and investigator sponsored research
• Lead core surveillance activities, signal assessment according to the product stage of development for multiple compounds, with oversight, as needed.
• Lead the creation and updates of EDSR  proactively collect, assess, identify, characterize, manage, and minimize emerging safety concerns across all aggregated clinical trials of a product during its development.
• Review of clinical documents for safety content (i.e. protocols, protocol amendments, clinical study reports).
• Contribute to the Filing activities for marketing authorization applications (MAA), new drug applications (NDA).
• Contribute to specified PV sections of the DSURs, PBRERs and safety data query responses to HAs including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries, with limited or no oversight, as needed.
• Provide guidance to junior scientists’ for reviewing and authoring of safety data/ad hoc queries and other documents.
• Contribute to the strategy and perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.
• Provide input for the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Partner with SMT Chair on the evaluation & management of signals emerging from any data source. Authors the Signal Report and tracks signals for other means of communication, with limited or no oversight, as needed.
• Facilitate the review and evaluation of Serious Adverse Reactions for inclusion in the Investigator Brochure Reference Safety Information (IB RSI), including presentation to SMT to ensure alignment. Author the IB RSI table for multiple products with limited or no oversight.
• Author documentation to support s