Shire Global Safety Lead (AD) in Cambridge, Massachusetts
The Global Safety Lead is the drug safety expert for assigned products; maintains current knowledge of full product portfolio and safety profiles for products. He/she is responsible for safety surveillance, risk management, and risk communication for assigned development and marketed products as well as medical assessment of individual adverse event reports, generation, and review of aggregate reports and safety documents, including labeling changes. This role provides drug safety support for internal and external customer.
· Responsible for appropriate review of all safety data from various sources (e.g. pre-clinical, clinical trial data, postmarketing, literature) throughout the development process as well as post marketing
· Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information
· Lead the Benefit-Risk Committee, responsible for management of ongoing and cross functional assessment of benefit risk profiles and related actions
· Responsible for key content of Risk Management documents (RMPs, REMS).
· Provide input in and support generation of periodic reports for assigned products; provide medical interpretation, review and approval for required reports
· Share Drug Safety and medical expertise with global counterparts in other functional areas such as Clinical
· Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
· Provide expert safety input to the clinical development program for assigned projects/brands
· Responsible for adequate and up to date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents
· Ensure, in collaboration with Regulatory Affairs labeling team accurate representation and communicate of the safety profile of assigned drugs or biologics
· Responsible for responses to inquiries from regulatory authorities on safety issues
· Provide integrated safety input into all regulatory documents where required
· Perform thorough assessment of safety profiles for Due Diligence project
· Provide Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters
· Perform Medical Review of all adverse event reports for seriousness, expectedness and causality
· Assist Scientists with medical opinion on obtaining follow-up information for individual cases.
· Participate in review of scientific literature: identify case reports that meet criteria for entry into the safety database; identify relevant safety articles / references involving the active ingredients of marketed products and products in development; and create literature summary sections to be included in PSURs and other required reports.
· Represent Global Drug Safety in leadership committees and activities both internally and externally when appropriate.
· Ensure communication of all Global PV and drug/biologic safety issues to Senior PV Management
· MD required with specialty training in functional area At least 1-4 years of experience in pharmaceutical industry within Drug safety/Pharmacovigilance with both investigational and marketed products
· At least 1 year of experience with aggregate reporting, safety surveillance, signal management and/or Risk management
· At least 1 year of Clinical Patient Care experience preferred
· Previous experience in bioscience preferred
· Product defense before a national or international regulatory authority a plus
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Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.