Shire Safety Analytics & Reporting Lead in Cambridge, Massachusetts
Responsible for ensuring high quality production of aggregate reports, Coordination of Safety Review Team meetings, signal detection activities, and clinical development and product registration activities. Supports the TA Head Medical Safety 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 Global Drug Safety and R&D stakeholders.
Responsibilities: % of time, Job Function and Description
15% Product management/oversight .
May manage a product or group of products or defined deliverables. 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 DSS. Fosters a collaborative culture within the product team and to external stakeholders. Ensures therapeutic product governance and communication in support of the Therapeutic Area Heads of Medical Safety and the Qualified Persons for Pharmacovigilance, including the EEA QPPV.
40% Oversight and Production of Aggregate Reports .
Oversees or is responsible for the production of periodic and ad-hoc safety reports for assigned therapeutic area products, where Shire is the Global Safety Database holder. Creates, coordinates, prepares and completes aggregate reports (e.g. PSUR/PBRER, DSUR, PADER, as well as ad hoc queries or reports) for submission to regulatory agencies worldwide. 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 (version control and archiving).
30% Safety Review Meetings and signal detection .
Oversees or is 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 per SOP requirements for signal evaluation reports and for responses to regulatory authorities.
Responsible for efficiently planning information submitted to the Internal Safety Review Committee and is the core coordinator of the Safety Review Team (SRT) meetings, ensuring that stakeholders provide input from their respective areas of responsibility.
15% Support for investigational products and registration activities .
Effectively collaborate with stakeholders external to GDS. Represent the GDS department in cross-functional programs, regulatory submission activities and provides GDS support for ongoing clinical developmental programs.
Education and Experience Requirements
Life Science Degree Healthcare Professional Preferred( Nursing, Physician Assistant, PharmD, MD etc.)
Post-graduate qualification in a relevant discipline preferred and clinical experience is a plus.
Minimum of 2 years previous experience in a global pharmaceutical Pharmacovigilance Department, preparing, authoring and submitting periodic safety reports
Key Skills, Abilities, and Competencies
Experience in the support of pre and post marketing surveillance as well as reporting to Regulatory Authorities worldwide.
Profound understanding of the drug development and regulatory process.
Practical experience in the interpretation of global Pharmacovigilance regulations and implementation within an industry setting.
Sufficient experience in the review and interpretation of safety data for investigational and/or post marketed products. Significant experience in the preparation of aggregate safety reports, including ICH-compliant PSUR/PBRERs and responses to ad hoc regulatory queries;
Facile with MedDRA and drug coding review.
Ability to contribute to the development and review of standard operating procedures and other process-related documents.
An engaging speaker with superior networking skills along with command of the English language in both oral and written communication and an ability to influence others within a matrix environment.
Able to work in a fast paced environment with demonstrated capacity to simultaneously manage competing tasks and demands.
Ability to work independently, take initiative and meet required 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 candidate will adapt quickly to changing business environment, be autonomous, while working in consultation with the other members of GDS and the respective Therapeutic Area Head for major decisions
Internal and External Contacts
Reports directly to the Therapeutic Area Head Medical Safety. Accountable to the EEA Qualified Person for PV and other senior stakeholders and/or customers. Interacts across multiple functions and 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. The Ability to quickly establish partnerships with stakeholders for strategic and operational needs of Shire is a must.
Other Job Requirements
May be required to travel domestically and internationally to other Shire sites and CROs or to external meetings (<10%)
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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.