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 contra indications, precautions, warnings and other risk mitigations, meeting internal and external standards and timelines; and accountable for all GPV 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
• Identifies, initiates and manages to completion, necessary updates to the IB, CCSI and/or local product information, Medication Guide, Patient Leaflet, and other labeling documentation as necessary
• Conducts medical evaluation of issues arising from PV Operations, such as use of the MedDRA dictionary and the IME list
• Provides medical input to ARGUS search criteria as necessary, including development of appropriate searches where no SMQ exists

You will need to have:

• MD Required
• Five years relevant safety and risk management experience in the pharmaceutical industry
• Knowledge and understanding of PV deliverables, standards and processes

• Broad and deep knowledge of the principles, concepts, and theories of drug-induced disease for therapeutic / product area(s)
• Excellent, independent judgment based on leading-edge knowledge and expertise
• Strong verbal and written communication including making recommended courses of action to management and/or senior leaders that impact the discipline, department or line, and influences their decisions.
• Sound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problems
• Ability to manage multiple overlapping complex tasks to conclusion, sometimes to tight timelines, for several projects and sub-projects, including oversight of others working on those projects
  

We would prefer for you to have:

• Prefer 4+ years in clinical medicine (post-training/residency)
• Rare, Ultra-Rare or Orphan Disease Area experience
• Strong personal time-management and project-management skills
• Collaborates and partners with internal and external teams to ensure consistency of actions and decision-making with overall development and/or commercial team strategies

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.