Alexion Pharmaceuticals Medical Director, Global Drug Safety in Boston, Massachusetts
This position can be based out of any Alexion office in the US, or virtual/remote, and may require up to 20% travel
The Medical Director, Risk Management Pharmacovigilance 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.
Job Duties & Responsibilities
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 sub team(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
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
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
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.