Shire Risk Management Lead in Cambridge, Massachusetts
The GDS - Risk Management Lead is the drug safety expert for assigned products; maintains current knowledge of assigned product portfolio and safety profiles for products. He/she is responsible for safety risk assessment, management, minimization and communication for assigned development and marketed products. He/she is also provides input into and review of aggregate reports and safety documents, including labeling changes.
Responsible for the implementation of benefit-risk management for Shire products. Development of REMS, DRMP’s & RMP’s, regulatory responses for risk management topics and other product position statements as assigned for submission to regulatory agencies.
Actively participates in Benefit- Risk Committees and other safety committees as needed. Effectively manages the Benefit/Risk process.
Prepares and assists in the management of Risk Management project timelines. Ensure all risk management documents are prepared according to regulatory requirements, facilitate review and sign-off. Ensure all regulatory commitments in RMP’s are followed & tracked.
Represent Risk Management on cross functional teams and Interface with other Shire functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed.
Communicates effectively on product risks to Risk Management Team Lead.
Provide advice and liaises with the Global Safety Leads that improve the consistency and accuracy of Benefit Risk assessment.
Critically review & provide medical/safety input of PBRER, RMP, DSUR, Clinical Expert statement, Regulatory responses, IB, NDA Submissions, MAA Submission & ad hoc reports. Ensures that the safety risks with Shire projects/products are identified promptly
Represent GDS- Risk Management for internal and external Risk Management forums as safety and risk management experts, including regulatory agency meetings such as EMA, FDA as needed,
Contribute to on-going process enhancement for safety surveillance such as developing standard procedures and templates
Participate in other activities, teams and committees as assigned
MD, PhD or Pharm D with specialty training in functional area at least 5 plus years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance with both investigational and marketed products
At least 3 year of experience writing and preparing risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies.
Previous experience in bioscience preferred
Product defense before a national or international regulatory authority a plus
Ability to read and analyze scientific and medical literature
Ability to work with interdisciplinary, highly matrixed team
Knowledge and active use of Microsoft Word, Excel, Powerpoint, Outlook, and Adobe Acrobat
Analytical and problem solving skills
Oral and written communication and interpersonal skills
Planning and Organizing
Ability to manage multiple projects simultaneously while remaining responsive to strict deadlines
Ability to establish and maintain professional communication both internally and externally with all stakeholders
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.