Senior Software Engineer

Job Role:

Role Location:

Roles & Responsibility:

• Subject Matter Expert for all questions relating to deliverables or applications.
• Monitors Docflow (calendaring system for aggregate reports) for upcoming reports and assigns an Aggregate Data Management Specialist.
• Refreshes preliminary tables at DLP-45 and sends to the Pfizer PSSR authors
• Receives request for tables from Pfizer.
• Communicate with requestor to get clarity on Table Requests.
• Answers questions on table generated from requestor.
• Generates all the requested data tables
• Quality control and peer QC of data table.
• Uploads tables into GDMS.
• Informs PSSR Authors that the data tables are available in GDMS.
• Creates aggregate case lists after the report was submitted to the agencies.
• Learning and maintaining a working knowledge of data table generation systems and tools (example GDMS, Pfast Business Objects, CSITag) and how these are applied.
• On-going liaison with PSSR Authors to ensure data table standards and deadlines for delivery are met.
• Recording of key information (including workflow) to support delivery of metrics
• Adhering to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.

Qualifications:

• Bachelors degree required, Scientific or information technology education desired.
• Experience in the pharmaceutical industry, or healthcare related field required.
• Previous experience in drug safety, medical information, or clinical research preferred

Knowledge and Skills:

• Knowledge of regulatory/safety regulations and guidelines desired.
• Experience working with databases required
• Strong written and oral skills required.
• Good understanding of medical and scientific terminology.
• Good understanding of computer technology, and management of relational database System.
• Good understanding of the software development lifecycle.
• Knowledge of Safety reporting systems and technologies.
• 1 year experience using Business Objects recommended. If experience is less than 1-year additional training required to be provided by Supplier before deploying in the project.