Associate Director, GDS Information Management

5 - 7 years experience  • 

Salary depends on experience
Posted on 03/20/18
Cambridge, MA
5 - 7 years experience
Salary depends on experience
Posted on 03/20/18

Primary Duties:

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.

Responsibilities:

60%:

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

GDS initiatives.

40%:

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

communication skills

-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

assessments

-Demonstrated ability to effectively develop and manage relationships with service providers

-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 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

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, Vendors,

Partners) in order to support business goals.

Other Job Requirements:

Travel may be required (<10%)

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