This position is an experienced analyst on the Global Drug Safety (GDS) Information Management team.
- Provide direct technical /data management support to ensure information entered and retrieved from the Global Drug Safety systems is consistent, accurate and complete.
- Provide 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.
- 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.
- 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.
Job Type: Contract
- Argus Safety: 4 years (Required)
- Global Drug Safety systems: 4 years (Required)
- SQL programming/querying: 3 years (Required)