Shire Global Drug Safety Information Management Lead in Cambridge, Massachusetts
This position is an experienced analyst on the Global Drug Safety (GDS) Information Management team. The Principal Analyst provides direct technical /data management support to ensure information entered and retrieved from the Global Drug Safety systems is consistent, accurate and complete. The GDS Principal Analyst is a technical expert in GDS for data management, reports and queries.
Ensure GDS data outputs are complete and accurate.
Drive the standardization of GDS information management (including implementation of self-service tools) to ensure consistency across solutions
Foster collaboration with stakeholders to ensure accurate interpretation of the business need.
Support Information Management tasks/projects requiring technical expertise with respect to Global Drug Safety
Support cross-functional information management initiatives.
Education and Experience Requirements:
Minimum: BA/BS and 5 years’ experience or equivalent.
3+ years Systems and/or Information Management experience in the Pharmaceutical, Device or Biotech industries or equivalent (Sponsor, CRO or combination)
1+ years of project leadership and global and/or cross-functional collaboration experience.
Preferred: Master's degree in a related field or MBA.
Key Skills, Abilities, and Competencies:
•Required: experience with Argus Safety, SQL programming/querying, custom report design/development preferably using a structured tool (e.g. Cognos, Business Objects)
•Excellent analytical, decision-making, organizational, managerial, interpersonal and communication skills
•In-depth knowledge of key aspects of Global Drug Safety processes
•Ability to interpret and apply regulatory requirements
•Technical understanding of Pharmacovigilance systems and software development methodologies
•Knowledge of systems integration and data interchange standards
•Proficient in the use of one or more of the leading Information Management Systems or programming environments
•Experience with analysis and support of continuous process improvement initiatives
•Current with industry developments, trends and opportunities
Complexity and Problem Solving:
Excellent technical, analytical and problem solving skills as it pertains to PV information management
Internal and External Contacts:
Interface and collaborate within the scope of the responsibilities above:
•With relevant counterparts in the regional and country Global Drug Safety functions to facilitate the global exchange of safety info
•Other functions within Global Drug Safety in all aspects of information management
•With other Shire groups (e.g. Clinical and Medical Affairs, Quality, Regulatory, IT, Legal, business units)
Develop and manage partnerships with External Service Providers (e.g. CROs, Central Labs and Recruitment Firms) in order to support business goals.
Other job requirements:
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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.