Newly combined with Baxalta, Shire is now the leading global biotechnology company focused on serving people affected by rare diseases and highly specialized conditions. These diseases are often misunderstood, undiagnosed and life-threatening. Our 22,000 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.
At Shire, we are dedicated to expanding, building and sustaining leadership across our key therapeutic areas through our extensive portfolio of products, innovative pipeline and collaborative approach to working with diverse partners around the globe. We strive to earn and keep the trust of our patients, their families and physicians, and all others who support and advance their care. Working together, the possibilities for our patients, healthcare partners and employees are unprecedented, with significant growth potential for our shareholders.
DSS, Therapeutic Area Head is responsible for managerial oversight of safety physicians by providing medical advice which improves the consistency and accuracy of Benefit Risk assessment. They are responsible for the strategy and implementation of safety and benefit-risk management for Shire products. Establishes the goals, and manage the day-to-day performance of safety physicians responsible for product support within assigned therapeutic area. Serves as member of the Shire Drug Safety Surveillance Team Leadership. Develops and maintains 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. Maintain therapeutic area knowledge and ongoing assessment of therapeutic area, competitive drugs and therapies. Responsible for the safety strategy during drug development, develop and maintain Risk Management Plans, recognize and manage safety signals, ensure the appropriateness of user information with respect to safety and significantly contributed to the global knowledge and understanding of the safety of assigned products.
Describe the essential job duties. After each, provide an estimate of the percent of time typically devoted to each responsibility (use increments of 5%, all time spent should total to 100% of time allocation). To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Please note the percentage of time spent on each job duty is an estimate for normal operating conditions.
•Managerial oversight of a group of team product safety physicians in DSS.
•Driving content of and supervising, mentoring and training the writing of Sections 6 and 9 for all PSURs and ad hoc regulatory queries
•Driving the strategy for and supervising, mentoring and training the writing of risk management plans for both internal use and regulatory submission
•Mentoring and training the implementation and execution of Safety Review Team practices, including integrated risk management and assessment activities throughout the product lifecycle
•Understanding the implications of the evolving US and global risk management guidances and legislation and translating to the Shire environment in order to evolve practices to meet regulatory expectations
•Personally assuming and overseeing work carried out on products and/or issues under highest scrutiny from patient protection and regulatory perspectives
•Developing and guiding presentations to the Executive Safety Review Committee
•Providing required support to the EU Qualified Person for Pharmacovigilance
•As part of the Drug Safety Surveillance Leadership team influence the strategy for Shire Global Drug Safety Organization.
•Act as senior leaders in Global Drug Safety ensuring excellent collaboration and networking within and outside of R&D.
•Providing input to strategic product placement from a safety perspective.
•Medical Degree required.
•Post-graduate training and regional certification in a subspecialty preferred
•At least 10-12 years of pharmaceutical industry experience, the majority in traditional and global pharmacovigilance departments, with at least 4 years of experience managing, mentoring and training other safety physicians. Prior positions in clinical research and/or medical affairs departments preferred
•Must have extensive current experience (preferably related to multiple products and therapeutic areas) in personally writing PSUR medical assessments, ad hoc safety query responses, and submissable risk management plans and in supervising, mentoring, training other safety physicians in this work
•Must have experience in implementing and running Safety Review Team type forums, with experience in implementing and mentoring a full range of integrated risk management and assessment activities throughout the product lifecycle
•Must understand the implications of the evolving global risk management guidance's and legislation and be able to translate to the Shire environment in order to evolve practices to meet regulatory expectations
•Strong post-marketing and investigational event and aggregate assessment/review/ documentation skills; must have experience is writing/oversight of Annual Reports, PSURs, Type II Variations, ad hoc query responses.
•Must have a strong working knowledge of US/EU regulations/ICH guidelines, and must be experienced in safety reviews of IBs, protocols, final clinical study reports, and summaries of safety
•Experience in communicating with the FDA and other global Health Authorities.
•Global drug safety experience preferred.
•Ability to read, analyze and interpret scientific and technical journals.
•Must have very strong English language writing skills and mature verbal communication and presentation skills.
•Working knowledge of MedDRA coding and experience in developing case series retrieval strategies.
•Must understand pharmacovigilance-related information systems and operations issues; prior oversight of these functions a plus.
•Experience using a large-scale electronic data storage and retrieval system.
•Requires strong attention to detail in composing and/or proofing materials, establishing priorities, scheduling and meeting deadlines.
•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.
•Proven ability to independently resolve problems and conflicts.
•Excellent interpersonal, analytical, managerial, and organizational skills.
•Demonstrated ability to motivate, mentor, influence and collaborate with others in a complex global organizational matrix.
•Ability to empathize and support staff working in other national environments.
•Travel will be required (10-15%), with some international
Incumbent will need to be a credible spokesperson to FDA and other Health Authorities and a decision maker within global product development teams relative to the interpretation of global PV guidance. Additionally, the incumbent will assist VP, Drug Safety Surveillance in setting pharmacovigilance and risk management strategy relative to products under high regulatory scrutiny and will take responsibility for all written documents relative to risk management plan progress reports and responses to ad hoc queries related to these products.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.