Senior Specialist Platform Technologies

Summary

The job description is for a Senior Specialist position in PharmaLex's Platform Technologies team. The role involves serving as a client service owner, contributing to requirements, providing day-to-day support, participating in projects, conducting training sessions, creating test plans, and maintaining knowledge bases. The candidate must have at least 3 years of experience in Pharmacovigilance, Safety Reporting, or Clinical Trials and a Bachelor's degree in computer or natural science.

Requirements

• At least 3 years of experience within the Pharmacovigilance, Safety Reporting, or Clinical Trials area in a pharmaceutical, biotech, or CRO company – and at least 2 years’ experience specifically with clinical trials or (safety) document distribution systems
• Bachelor of Science in computer or natural science, or a comparable education

Responsibilities

• Serve as a client’s service owner to ensure the client’s core business needs are met by psiXchange – and proactively share feedback, and new requirements & ideas with internal teams
• Contribute, track, and provide feedback on requirements to help fix and/or enhance psiXchange functionality. Participate in testing of developed features and corrected defects
• Provide day-to-day expert business and functional support to psiXchange clients (as the first-line vendor support), including consultation on client configuration requests
• Participate in client implementation and upgrade projects, including with validation and migration activities
• Conduct client and internal training and workshop sessions
• Create, maintain, and/or execute high quality test plans and scripts for both client projects and/or internal regular & hot-fix releases
• Create and maintain training materials, user manuals, and release notes in support of new psiXchange releases
• Proactively monitor client environments to ensure optimal availability and early detection of client system issues – including creating customer system health reports
• Develop and maintain knowledge base(s) and support tools to continuously improve Business Services capabilities
• Assist in developing pertinent Policies, SOPs, and WINs

Preferred Qualifications

• Strong communicator fluent in English; German beneficial
• Autonomous, concentrated, and highly organized with strong attention to detail and keen analytical skills – and the ability to efficiently multi-task and handle competing priorities
• Ability to work enthusiastically and collaboratively as part of a cohesive group and also independently, as needed
• Proactive approach to ensuring continuous improvement and growth for oneself, the Business Services Team, and the Pharmasol organization
• Technical experience, such as general knowledge of database structures/models and with writing SQL queries, beneficial
• Good knowledge of Computerised Software Validation (GAMP 5) and 21 CFR Part 11
• Project management experience preferable