.This is what you will do :The Medical Director, Global Patient Safety is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion's products by patients and healthcare providers.The jobholder utilizes subject matter clinical and pharmacovigilance expertise, combined with knowledge of the product(s) or therapeutic area to identify and evaluate safety signals and to drive decision-making on risk / benefit evaluation and argumentation, pharmacoepidemiological or clinical trial data interpretation, and risk assessment.The Medical Director, Risk Management Pharmacovigilance is an individual contributor role and reports to the Senior Medical Director, Risk Management Pharmacovigilance.You will be responsible for :Leads risk management evaluation and resolution for assigned products and projects. Accountable for the following :Through data review and research, identifies for monthly Safety, Risk Management and Safety Science Management Team meetings, issues that could be potential signals for observed adverse events for further review and analysis.Directs the Safety Management Team for the assigned project(s) or product(s) ensuring a safety and risk / benefit driven agenda from inception to closure.Represents GPV on other project / product team(s) or subteam(s), ensuring processes for timely collection and processing of adverse events, assessment of suspected adverse reactions, and identification of contraindications, precautions, warnings and other risk mitigations, meeting internal and external standards and timelines; and accountable for allGPV deliverables relating to the project / product.Collaborates with external resources such as Clinical Operations and Clinical Scientist on the identification of and resolution for potential signals.Detects, validates and manages pre-and / or post-approval safety signals through to resolution.Ensures timely, accurate recording of risk management action plans and decisions, and project manages GPV deliverables as appropriate to ensure completion on time to applicable standards.Conducts medical assessment of causality of Individual Case Safety Report (ICSR) as necessary, including the assessment of quality within the ICSR process; identifies process improvement opportunities and drives changes in process.Evaluates aggregate safety data and writes contributions to its interpretation for Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, IB, CCSI, Safety Summaries and Clinical Overviews for the CTD, and other routine and non-routine safety and risk / benefit evaluations for internal or regulatory purposes as required.Provides medical interpretation of complex PV and pharmacoepidemiological data to enable clinical and regulatory decision-making
