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Global Drug Safety Compliance Lead

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POST DATE 9/2/2016
END DATE 12/1/2016

Shire Pharmaceutical Lexington, MA

Lexington, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Job Description
This position contributes to the quality and compliance outputs for Global Drug Safety through development and execution of the R&D Quality Management system and compliance monitoring systems based on global regulatory standards. Fosters a culture of continuous process improvement and identifies opportunities to further enhance quality and compliance.

Drives Pharmacovigilance compliance based on expectations and/or requirements of regulatory agencies, internal processes, and external business partner obligations.
Evaluates responses and corrective and preventative action plans (CAPAs) to audit findings for adequacy and timeliness, reviews implementation, and manages the closeout of all corrective and preventative actions.
Develop, evaluate and monitor internal/external compliance metrics.
Alert management, including EU QPPV, of significant deficiencies in quality or compliance standards including proposed corrective/preventative actions
Monitors, reviews and makes recommendations regarding processes and guidelines with emphasis on compliance standards.
Develop and execute method for tracking partner compliance to the safety agreement.
Conduct internal assessment of Shire PV compliance with process and contractual obligations
Participate in business partner audits of Shire and support QA&C audits of business partners. Support regulatory inspections
Provides support during regulatory inspections at Shire.
Work with key stakeholders to define and ensure compliance with global business and regulatory requirements.
Other tasks as assigned

Bachelor s degree in a scientific discipline or related field, preferably Health Care Professional
Strong work ethic and the capacity to work in a fast-paced environment; flexible and quickly adaptable to changing priorities
A minimum of 5 years prior experience in drug safety/pharmacovigilance in a global setting
Experience with both investigational and marketed products
Having worked internationally and in ex-US territories is a plus
Expert knowledge of global PV regulations

May require limited travel both domestically and internationally.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

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.

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.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

Reasonable Accommodations
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.