Argus Safety Analyst & ProgrammerApply Now
Location: Waltham, Massachusetts 02451
Employment Type: Contract
Contract Length: 6 months
Job Summary: This individual supports the DSPV Systems & Analytics team in database validation and configuration activities, and in the fulfillment of data requests.
- Collaborate cross functionally to understand and analyze the impact and scope of project.
- Collaborate with the safety system hosting vendor to develop and implement system changes as needed (e.g., product configuration, protocol configuration, workflow changes, user access changes, etc.).
- Identify and respond to issues concerning Safety System and application components (Argus Safety, Analytical Tools, etc.).
- Provide technical support and implement solutions for system configuration changes (e.g., enhancements, new functionality requests, and troubleshooting),
- Contribute to process improvements related to the DSPV safety system.
- Organize data using Excel to create tables and charts to facilitate data analysis for aggregate data review as well as for signaling activities
- Development, Review, Execution, and Monitoring of the system qualification ( IQ, OQ, PQ scripts and protocols, summary reports) deliverables
- Responsible for technical issue resolution including diagnosis of problem, recommendations for workarounds, and defect correction.
- Analyze, designs, implement enhancements/changes to system.
- Strong knowledge and experience with the safety system (Argus Safety) including PV operation, technical, and analytical skills.
- Must be proficient in Microsoft Excel, Word, and PowerPoint.
- Must have proficiency in Oracle SQL/PL SQL and query tools
- Strong knowledge of relevant FDA/GCP/ICH guidelines and AE reporting requirements.
- Must have experience with MedDRA and WHO Drug coding dictionaries.
- Proficiency with use of Adobe Acrobat (Reader and Writer), Microsoft XL and Microsoft Word.
- Minimum Bachelor’s degree in life sciences, computer science, or health-related field.
- 5-6 years of experience supporting a Drug Safety database in a pharmaceutical company, or equivalent.
He's a natural people person.
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