Medical Director, Pharmacovigilance - United States
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This is a substantive project-level leadership role in Global Pharmacovigilance (GPV), accountable for the identification and communication of safety issues and the management of risks arising in one or more assigned clinical development projects or marketed products.
Possessing broad and deep knowledge of the principles, concepts, and theories of drug-induced disease, the Risk Management Lead provides medical and pharmacovigilance expertise and judgment on, and leads team decision· making about, complex risk/benefit evaluation and argumentation, pharmacoepidemiological or clinical trial data interpretation, and risk assessment, making use of preclinical and CMC evidence as well as human data from all sources. Through well-considered data evaluation, the RML influences content of internal and/or external clinical and PV documents for strategic and regulatory purposes, such as risk management plans, clinical expert reports/overviews and targeted responses to safety issues. The RML makes significant business impact by correctly identifying and managing risks to patients of drug candidates, through influencing Regulatory decisions
e.g. by providing high-quality clinical summaries and risk/benefit argumentation that assure probability of Regulatory success, and by enabling the safe and effective use of Alexion's products by patients and healthcare providers.
- Chair a regular Safety Management Team for the assigned project(s) or product(s), setting a safety and risk/benefit driven agenda from inception to closure
- Represent 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
- Lead the detection, validation and management of 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
- Medical assessment of causality of ICSRs as necessary, including the assessment of quality within the ICSF process
- Medical evaluation of aggregate safety data, and written 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
- Identify, initiate and manage to completion, necessary updates to the IB, CCSI and/or local product information, Medication Guide, Patient Leaflet, and other labeling documentation as necessary
- Medical evaluation of issues arising from PV Operations, such as use of the MedDRA dictionary and the IME list
- Medical input to ARGUS search criteria as necessary, including development of appropriate searches
- where no SMQ exists
- May represent GPV at internal strategic and/or advisory/governance committees,
- May represent Alexion or act as an external technical resource, for example at DSMB or Regulatory Authority meeting or pharmaceutical industry conference
- Extensive relevant experience over 8+ years, in drug development, pharmaceutical safety and risk management, signal detection, validation and management, gained in the pharmaceutical industry, or a regulatory or academic environment.
- Leads across teams and across GPV to develop and review complex recommendations to the teams and senior leaders.
- MD required
Lexington, MA, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
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. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer