Shire Safety Analytics & Reporting Lead in Cambridge, Massachusetts
Responsible for ensuring high quality of aggregate report production, Safety Review meeting coordination, signal detection activities, and clinical development and product registrational activities. Supports the Safety Analytics & Reporting Team Lead to ensure that their responsibilities as SA&R Lead are in accordance with global regulations and in collaboration with the Global Safety Leads physicians and other key PVRM and R&D stakeholders. Responsibilities % of TimeJob Function and Description20 Product management/oversight .May act as a mentor to PV Scientists or as a manager for a product or group of products. Oversees and assumes responsibility for assigned therapeutic products and PV activities through the lifecycle of the product.Supports an organizational structure that meets the evolving needs of Shire and the GDS department. Fosters a collaborative culture within the product team and to external stakeholders. Ensures therapeutic product governance and communication in support of the SA&R Team Lead, Heads of Medical Safety and SA&R and the Qualified Persons for Pharmacovigilance, including the EEA QPPV.30 Aggregate report production .Responsible for the production of periodic and ad-hoc safety reporting for therapeutic team products, where Shire is the Global Safety Database holder. Creates, coordinates, prepares and completes aggregate reports (e.g. PBRER, DSUR, PADER, as well as ad hoc queries or reports) for submission to regulatory agencies around the world. Collaborates with the Global Safety Lead to ensure that all information is available to allow for informed medical review and benefit-risk assessment. Responsible for the quality of the final document and uses Shire’s EDMS system to provide quality control.30 Safety Review Meetings and signal detection . Responsible for the technical and scientific support for safety surveillance and signal detection activities for assigned Shire products via established signal detection methodology and tools. Evaluate signals promptly in signal detection reports and ad-hoc responses to regulatory authorities.Responsible for efficiently planning Internal Safety Review Committee and Safety Review Team (SRT) meetings, ensuring that stakeholders provide input from their respective areas of responsibility.20 Support for investigational products and registration activities . Effectively collaborate with stakeholders outside of GDS. Represent GDS department in cross-functional clinical programs and registrational activities and provide GDS support for clinical developmental programs. Education and Experience Requirements
Life Science Degree or Healthcare Professional.
Post-graduate qualification in a relevant discipline preferred.
Minimum of 5 years’ experience in a pharmaceutical company preparing, writing, authoring and submitting periodic safety reports.
Key Skills, Abilities, and Competencies
Experience in the support of post marketing surveillance and reporting to Regulatory Authorities worldwide.
Solid understanding of the clinical development and regulatory process.
Practical experience in the interpretation of global Pharmacovigilance regulations and implementation within an industry setting.
Competence in conducting safety data reviews for investigational and/or post marketed products.
High level of expertise and experience in the preparation of aggregate safety reports, including ICH-compliant PBRERs and responses to ad hoc regulatory queries; significant experience in the mentoring, training and assessment of staff involved in the preparation of aggregate safety reports.
Experience with MedDRA and drug coding reviews.
Ability to contribute to and review standard operating procedures and other process-related documents.
Excellent communication, collaboration and networking skills.
Strong understanding of the interface between Pharmacovigilance and external departments.
Ability to influence others within a matrix environment.
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.
Forward-planning and proactive.
Complexity and Problem Solving Support global decision-making and direction setting, including devising of future strategy and the management of complex tasks. It is expected that the incumbent will adapt quickly to changing business and healthcare needs, and be autonomous, while working in consultation with the SA&R Team Lead on the implementation of major decisions Internal and External Contacts Reports directly to SA&R Team Lead. Accountable to the EEA Qualified Person for PV and other senior stakeholders and/or customers. Interacts across multiple functions and geographic locations and supports senior levels of the organization. Particularly important relationships are with Global Clinical Development, Regulatory Affairs, Medical Affairs, and Non-clinical Development. Key external contacts include regulatory agencies, contract research organizations and vendors. Needs to be able to form partnerships with key stakeholders that address the strategic and operational needs of Shire. Other Job Requirements May be required to travel domestically and internationally to other Shire sites and CROs or to external meetings (<10%)
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.