This position is a senior member of Global Drug Safety (GDS) Information Management team.
While a substantial amount of this role’s responsibilities will include ownership of day-to-day
operations, the Associate Director will also help define strategies and translate them into
operational plans for GDS Information Management. This role will drive short- and long-term
initiatives for the department.
Deliver access to Shire Global Drug Safety information via self-service, ad hoc
and custom mechanisms.
Own the complete lifecycle (concept through implementation/maintenance) of
compliant, effective and efficient safety information management solutions.
Act as principal GDS IM representative for audits, inspections and other internal
Lead GDS and cross-functional teams to implement new and updated business
intelligence and systems solutions with Global Drug Safety impact.
Represent GDS Information Management on integration and project teams.
Education and Experience Requirements:
BA/BS and 7years’ experience or equivalent.
5+ years Systems and/or Information Management experience in the Pharmaceutical, Device or
Biotech industries or equivalent (Sponsor, CRO or combination)
3+ 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
-In-depth knowledge of key aspects of Global Drug Safety processes
-Ability to interpret and apply regulatory requirements
-Experience in the planning, conduct and documentation of qualification and compliance
-Demonstrated ability to effectively develop and manage relationships with service providers
-Technical understanding of Pharmacovigilance systems and software development
-Knowledge of systems integration and data interchange standards
-Proficient in the use of one or more of the leading Information Management Systems or
-Experience leading continuous process improvement initiatives with a proven track record of
success as measured by return on investment
-Current with industry developments, trends and opportunities
Complexity and Problem Solving:
Excellent technical, analytical and problem solving skills as it pertains to PV information
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,
Develop and manage partnerships with External Service Providers (e.g. CROs, Vendors,
Partners) in order to support business goals.
Other Job Requirements:
Travel may be required (<10%)