Newly combined with Baxalta, Shire is now the leading global biotechnology company focused on serving people affected by rare diseases and highly specialized conditions. These diseases are often misunderstood, undiagnosed and life-threatening. Our 22,000 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.
At Shire, we are dedicated to expanding, building and sustaining leadership across our key therapeutic areas through our extensive portfolio of products, innovative pipeline and collaborative approach to working with diverse partners around the globe. We strive to earn and keep the trust of our patients, their families and physicians, and all others who support and advance their care. Working together, the possibilities for our patients, healthcare partners and employees are unprecedented, with significant growth potential for our shareholders.
The Pharmacovigilance Risk Management Lead is responsible for Risk Management and Pharmacovigilance Plans and risk management activities for Shire products, including the management of the operations of benefit risk committee and resulting action plans
• Development and management Risk Management and Pharmacovigilance Plans and risk management activities for Shire products, including the management of the operations of benefit risk committee and resulting action plans
• Summarize safety data from investigational and marketed use
• Authoring RMP's, REMS to meet regulatory and internal deadlines.
• Critically review documents produced for scientific content and alignment with company position, clarity, accuracy, and consistency and f facilitate document review by other contributors
• Ensure all safety regulatory documents are processed and submitted according to regulatory requirements
• Manage portfolio of products/projects related to risk management
• Write and prepare risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies
• Ensure all risk management documents are prepared according to regulatory requirements and facilitate review and sign-off
• Assist in the management of Risk Management project timelines
• Represent Risk Management on cross functional teams
• Interface with other Shire functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed
• Contribute to on-going process enhancement for safety surveillance such as developing standard procedures and templates
• Participate in other teams and committees as assigned
• MD, PHD, or Pharm D with specialty training in functional area at least 4 plus years of experience in pharmaceutical industry within Drug safety/Pharmacovigilance with both investigational and marketed products
• At least 3 years 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
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.