Senior Specialist Platform Technologies

vor 7 Monaten

Hamburg, Deutschland Pharmalex Vollzeit

**We are growing, grow with us**
Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? Then, PharmaLex is your career choice
PharmaLex is part of Cencora - the leading service provider for the pharmaceutical, biotech and medical device industries globally. PharmaLex is specialised in effectively designing all aspects of drugs and medical devices regulatory needs, ranging from early development and market entry to product maintenance activities.

We are looking for an additional team member to join remotely our Platform Technologies team.
A great opportunity for a Pharmacovigilance expert who would like to work with internal departments, as well as clients..

**Senior Specialist Platform Technologies**

**Your Job**
- Serve as a client’s service owner (advocate) 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.
- Any other responsibilities as discussed and agreed to with Supervisor, including any other Platform Technologies strategic initiatives.

**Your Profile**
- 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.
- 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

For further information please don’t hesitate to contact us.

Agencies only by prior agreement for the specific job opportunity.

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