Shire Global Safety Lead (DIR) in Cambridge, Massachusetts
The Global Safety Leader is a senior drug safety expert for assigned products; maintains current knowledge of full product portfolio, monitors the safety profiles for assigned products and development compounds while mentoring DDS scientists. 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. Collaborates with the Therapeutic Area Head to develop the strategic roadmap for managing the safety of assigned products and development compounds. Participate in due diligence activities and special projects as needed.
•Responsible for the medical safety review of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products and development compounds
•Responsible for conducting signal detection activities, monitoring, evaluation, interpretation, management and communication of safety information
•Leads the Safety Review Teams for assigned products and development compounds and is responsible for the management of ongoing and cross functional assessment of benefit risk profiles along with the related actions, including writing and updating of the benefit-risk documents for assigned products and development compounds
•Provides medical expert safety review input into all critical documents for products in clinical development (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs)
• Collaborated with the Therapeutic Area Head to develop and implement the strategy for benefit-risk management for assigned products.
•Responsible for the important Medical content of Risk Management documents (RMPs, REMS)
•Provides input into and support the writing of periodic reports for assigned products; provide medical interpretation, review and approval for required reports
•Shares Drug Safety and medical expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal. •Provide expert safety input to clinical development programs for assigned products and development compounds
•Responsible for the appropriate and timely safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents •Ensure, in collaboration with Regulatory Affairs labeling team an accurate representation and communication of the safety profile of assigned products and development compounds
•Responsible for the medical content of responses to inquiries from regulatory authorities related to safety topics
•Provide integrated safety input into all regulatory documents where required
•lead the assessment of clinical safety for Due Diligence project
•Provide Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters
•Responsible for the medical review of adverse event reports for seriousness, expectedness and causality •Assist Scientists by providing medical opinion regarding the necessary follow-up information for individual cases.
•Participate in review of scientific literature: identify case reports that meet criteria for entry into the safety database; identify relevant safety articles / references involving the active ingredients of marketed products and products in development; and create literature summary sections for PSURs and other required reports. •Represent Global Drug Safety on leadership committees and related activities both internally and externally as required.
•Ensure communication through governance of all safety topics/issues where that may impact the benefit-risk profile of assigned products/development compounds to Senior GDS management. This includes preparing presentations to the Internal Safety Review Committee
•Provide applicable medical safety input to clinical team decisions
•Communicating effectively regarding product issues and proposes solutions to senior management as well as the Office of the EU Qualified Person
•Develop and maintain strong relationships within assigned therapeutic areas with other stakeholders including Clinical Development Teams, Regulatory Affairs, Licensing and Marketing to better understand and fully support business objectives.
•Participates in activities related to inspection readiness as it pertains to assigned products and audit of clinical studies for assigned development compounds
•Continuously accrue therapeutic area knowledge and ongoing assessment of therapeutic area, competitive products and therapies.
• Be visible as the goto person responsible for the safety strategy during drug development, develop and maintain Risk Management Plans, recognize and manage safety signals, ensure the suitability of user information with respect to safety and significantly contributed to the global knowledge and understanding of the safety of assigned products.
Education and Experience Requirements
MD, DO or equivalent education required.
•At least 6 years of experience in pharmaceutical industry and at least 4 within Drug safety/Pharmacovigilance for both investigational and marketed products.
•At least 4 years of experience with aggregate reporting, safety surveillance, signal management and/or Risk Management.
•At least 3 years of hands-on Clinical Patient Care experience preferred
•Product defense before a national or international regulatory authority a plus
•Argus ,Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat
•Analytical and problem solving abilities and capacity to handle multiple projects
•An engaging communicator with superior people skills
•Command of the English language ;both oral and written communication.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
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.