The Global Drug Safety Risk (GDS) 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. Responsibilities
Education and Experience Requirements
- 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 .
Key Skills, Abilities, and Competencies
- MD, PhD, Pharm D, or Master's degree in a science or healthcare related discipline with specialty training in functional area and at least 3 plus years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance with both investigational and marketed products
- At least 2 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.
Complexity and Problem Solving
- 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
Tactical day-to-day decisions should be made by this person, while longer-term strategic decisions should be in collaboration with the Risk Management Team Lead and/or Head of Risk Management Strategy Internal and External Contacts
Will regularly interact with internal stakeholders; e.g., GDS colleagues, HEOR & Epi, Medical Information, Regulatory Affairs, Legal, Corporate Compliance, Clinical Medicine, Medical Affairs, Commercial, Corporate Communications, and Supply Chain. Liaise and manage vendors activities. Other Job Requirements
Required to travel domestically and internationally to other Shire sites and external meetings. Driver's license optional but preferred.