This position actively participates in and assists management in maintaining the quality and compliance of the Global Drug Safety organization through development & maintenance of global processes, departmental standards, and developing & conducting training while fostering a culture of continuous process improvement and identifying opportunities to further enhance quality and compliance.
50%: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.
20%: Design, develop, implement, and facilitate training on Pharmacovigilance topics and GDS procedures as needed including appropriate documentation.
10%: 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.
10%:Manage curriculum for GDS staff and work with the PST team to remediate any gaps or issues. Develop evaluation and assessment strategies for the department learning objectives. Continually assess department training needs to identify areas for improvement. Maintain and conduct new hire on-boarding activities.
10%:Manage special process or training related projects as directed by Head of GDS PST.
Education & Experience Requirements:
• Bachelors of Science degree preferred in medical or science-related field
• 5+ years in pharmaceutical industry preferably in pharmacovigilance, QA, clinical development, 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
• Technical expertise with databases (Access, TrackWise, Argus, etc.) and document management systems
• Knowledge of Quality Management Systems, FDA/EU regulations and ICH guidelines for GVP and GCP
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.
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.
EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy
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.