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.
Reporting to the Senior Director, Post marketing Surveillance and Study Team Lead responsibilities include: (1) facilitate and develop Post marketing surveillance study protocols and study reports, (2) Coordinate, contribute, and monitor Post marketing Surveillance Study commitments for Shire marketed products.
Post marketing Surveillance Studies
•Under the oversight of the Post marketing Surveillance and Study Team Lead, coordinate, write, and contribute to the development of post marketing study(s) and related commitments/documents for Shire products.
•Develop protocols, study timelines and project management for post marketing studies, including Japan-DURS or similar and additional Risk Management Plan (RMP) commitments, such as EU- educational materials effectiveness surveys, US- REMS, etc. as assigned for submission to regulatory agencies.
•Prepares and assists in the management of Post marketing Study project timelines. Ensure all Post marketing Study documents, including interim and final study reports are prepared according to regulatory requirements, facilitate review and sign-off. Ensure all regulatory commitments in RMP's are followed & tracked, particularly post marketing study commitments.
•Analyze and interpret epidemiology and Post marketing Surveillance data to assess benefit/risk of the product.
•Collaborate with the R&D functions in support of studies, projects and activities undertaken as part of RMP commitments.
•Contribute to surveillance activities.
•Provide primary point of contact and manage relationships with service providers.
•Maintain awareness of worldwide Regulatory Guidance on Post marketing studies, Drug Safety Surveillance and Risk Management Plans.
•Provide advice and liaises with the Global Safety Leads to improve the consistency and output of protocols, related negotiations, responses and finalization with regulatory agencies.
Represent GDS Post marketing Surveillance •Participates and presents discussion topics in Protocol Review Committees, Safety Review Teams and other safety committees as needed. Effectively manages the Post marketing Surveillance commitments and contributes to the benefit-risk process.
•Represents Post marketing Surveillance team on cross functional teams and interfaces with other Shire functional groups such as Regulatory Affairs, Clinical Development, Clinical operations, Medical Affairs, Compliance, as needed.
•Liaise effectively with Shire local country offices and local affiliates in the understanding of local and country regulations which affects the Post marketing commitments including, development and implementation of Post marketing studies.
•Communicates effectively on product risks to senior management, the Qualified Person for Pharmacovigilance (QPPV) and Regional PV Directors.
•Critically review & provide medical/safety input of MAA Submission and ad hoc submission responses, product license renewals, PBRER, RMPs, Regulatory responses and IB. Ensures that the study timeline risks with Shire Post marketing Surveillance projects are identified promptly and mitigation plans are put in place.
•Represent GDS- Post marketing Surveillance for internal and external Post marketing Study forums as safety and Post marketing Surveillance experts, including regulatory agency meetings such as EMA, FDA as needed •Participate in other activities, teams and committees as assigned Post marketing Surveillance Process improvement •Contribute to ongoing process enhancement for Post marketing Surveillance/studies and safety surveillance in general such as developing standard procedures and templates •Propose and implement improvement in protocol development and study report writing and monitoring processes.
•Master's degree in a science or healthcare related discipline •Formal training or equivalent experience in epidemiology, public health, and/or risk management.
•Experience in Drug Safety or Pharmacovigilance.
•Experience in a medical field is preferred.
•Generally has 3+ years of experience in developing and implementing Risk Management Programs for pharmaceutical products.
•Ability to improvise and demonstrate creativity in solving problems and achieving objectives .
•Proficiency with electronic search engines of the medical literature (MEDLINE, EMBASE, etc.).
•Ability to read and analyze scientific and medical literature.
•Ability to work with interdisciplinary, highly matrixed team.
•Knowledge of global regulations and guidance on risk management.
•Knowledge of Shire involved therapeutic areas, disease management, treatments, etc.
•Requires strong attention to detail in composing and proof-reading materials, establishing priorities, scheduling and meeting deadlines.
•Excellent written, oral communication and presentation skills.
•Experience in Project Management.
•Must be able to work in a fast paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
•Ability to work independently, take initiative and complete tasks to deadlines.
•Working knowledge of MedDRA terminology and practices is a must.
•Good working knowledge of MS Word, Excel, PowerPoint and Outlook.
Required to travel domestically and internationally to other Shire sites and external meetings.
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.