- Expiry Date: 11 February 2022
Research and Development / Global Regulatory, Safety and Biometrics /
Worldwide Patient Safety/Epidemiology, Safety Science Capabilities and Innovation (ESSCI)
The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams. Appropriately perform core signal detection activities and elevate program or portfolio issues impacting key MST programs, priorities, resources, and milestones with appropriate oversight. Author responses for safety data queries and contribute to specified PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR). Ensure pharmacovigilance regulatory compliance with oversight, as needed.
General Product Support
Supports Medical Safety Assessment Physician (MSAP) leading signal detection activities for a product's emerging safety profile.
Prepare/write PV sections of aggregate safety documents (eg, DSUR, PBRER) and analyze data for the RSI section of the IB. Write and analyze data for ad hoc responses to health authorities, with oversight.
Execute strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document signal by Safety Topic Review/ Signal Report.
Analyze data and prepare documentation to support label updates for assigned products, with oversight.
Support Safety input for regulatory product labeling.
Support the EU QPPV or other regional or local Qualified Person for safety issues relating to assigned products.
Working knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings.
Clinical Development & Post Marketing Product Support
Perform core surveillance activities, signal assessment according to the product stage of development for a multiple coumponds, with oversight, as needed.
Lead Safety Data Review Meetings (SDRM) in the review and evaluation of clinical data to support signal detection. Appropriately elevate issues impacting key SMT activities, milestones, and documents to the SMT Chair with oversight, as needed.
Contributes 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 oversight, as needed.
Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.
Executes 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 Safety Topic Review/ Signal Report and tracks signals for other means of communication, with oversight, as needed.
Perform the review and evaluation of SARs for inclusion in the IB RSI, including presentation to SMT to ensure alignment. Author the IB RSI table, for less complex products with oversight, as needed.
Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile, with oversight as needed.
Support preparation for regulatory inspections and audits with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
Support hiring & orientation.
Cross Functional Activities
Support process improvement and cross-functional initiatives for Safety Science including SOPs and Procedural Documents.
Builds cross functional relationships with SMT membership and stakeholders
Seeks feedback and best practices for continued development
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