Shire Global Drug Safety Compliance Lead in Cambridge, Massachusetts
This position actively participates in and assists management in maintaining the quality and compliance of the Global Drug Safety organization through development and execution of global and departmental processes, PV standards, and compliance monitoring systems while fostering a culture of continuous process improvement and identifying opportunities to further enhance quality and compliance.
% of Time
Job Function and Description
Manage creation/revision of assigned procedural documents including cross-functional documents. Liaise with GDS and cross-functional subject matter experts as necessary. Maintain department-specific documentation in support of the PV system in a document management system as directed.
Evaluate legislation and guidance related to pharmacovigilance system. Work with SMEs to identify gaps with current process. Present gaps as well as potential solutions to management. Ensure changes to legislation are reflected timely in GDS process documents.
Assist with audit preparation, document retrieval and tracking, and aid with audit finding responses as directed by the Head of PV Compliance and Training. Participate GDS related inspections and audits.
Provide support to globalization and company integration projects impacting the pharmacovigilance system.
Manage the generation and maintenance of the Pharmacovigilance System Master File and similar documents as required globally.
Manage special projects as directed by Head of GDS Quality & Compliance.
Education and Experience Requirements
Bachelors of Science degree preferred in medical or science-related field
5+ years in pharmaceutical industry preferably in pharmacovigilance, Quality Assurance, or similar department
3+ years’ experience procedural document creation or revision
Strong understanding of drug safety processes, FDA and other national or international regulations, and ICH guidelines required
Strong project management skills required
Practical experience in the interpretation of PV regulations and implementation
Experience with databases (TrackWise, Argus, etc.) and electronic document management systems
Knowledge of Quality Management Systems, FDA/EU regulations and ICH guidelines for GVP and GCP
Key Skills, Abilities, and Competencies
Requires strong attention to detail in establishing priorities, scheduling and meeting deadlines
Ability to work independently, take initiative and complete tasks while keeping management updated
Ability to interpret PV regulations and analyze gaps and identify opportunities to implement
Ability to identify resolutions and to resolve conflicts with direction from management
Excellent interpersonal, communication, analytical and organizational skills
Complexity and Problem Solving
Ability to propose and implement change to PV system based on regulations, organizational changes, with final decision being with upper management
Be able to propose procedural changes, training opportunities, measures to maintain and improve compliance and present to management for final decisions
Make day-to-day decisions regarding compliance keeping management informed
Internal and External Contacts
Accountable to the head of GDS Quality & Compliance.
Frequent interaction with but not limited to GDS personnel at multiple levels, QA & Compliance, business partners, Regulatory Affairs, vendors
Other Job Requirements
Domestic or international travel may be required <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.