The GDS - Risk Management Team 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 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. Key Responsibilities:
- Responsible for the strategy and 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.
- In support to the Head of Drug Safety Surveillance, supervises assigned team of Risk Management specialists for various therapeutic areas and/or products. Supervision and support includes but not limited to:
- Assignment of products and representation of Risk Management support within Global Drug Safety and Shire.
- Taking accountability while supporting the individual Risk Management specialist and assigned Risk Management team and multiple project deliverables.
- Supporting the Risk Management specialists in prioritization and expert advice for efficient planning for quality outputs.
- Reviewing work outputs, documents, etc. produced by the specialists and providing critical review and expert thinking before agreeing for further review by Global Drug Safety and other line functions.
- Providing back up support for the Risk Management Specialists and projects as needed.
- Mentoring and development of the Risk Management Specialists.
- Ensuring performance and alignment of personal and team roles to Global Drug Safety goals and objectives
- Participating in further development of Risk Management and / or Global Drug Safety processes and outputs.
- 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 senior management and the Office of the EU Qualified Person.
- Management of GDS- Internal Safety Review Committee and Shire's highest safety governance Executive Safety Review Committee meetings.
- Provide advice and liases 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 10 plus years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance with both investigational and marketed products
- At least 5 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
- 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