Drug Safety Process Support Expert (m/f/d)

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

What the job looks like

Each day you'll enjoy a variety of challenges, such as:
 

• Managing the IT applications within Drug Safety together with the Drug Safety team members and in close collaboration with Global IT
• Development of custom solutions and applications for the IT system landscape in Global Drug Safety
• Creation of complex database output for internal and external recipients with Business Intelligence tools
• Supporting and leading IT projects within Global Drug safety in collaboration with business including but not limited to system upgrades, implementation of new applications etc.
• Performing and leading validation activities for Drug Safety specific applications
• Driving the appropriate setup and development of drug safety processes along with the respective business functions to meet various business and regulatory requirements in the most efficient manner
• Support of portfolio changes, mergers, acquisitions and divestitures from IT perspective
• Representing Global Drug Safety in cross-departmental projects as required
• Active participation in industrial working groups from drug safety IT systems perspective
• Providing out of office support as required in accordance with the respective company policies

What you’ll bring to the table

To make the most of this role and truly thrive, you should have:
 

• Educational background as software engineer, system integrator, IT administrator or similar
• Several years of experience in pharmaceutical industry incl. Drug Safety application & business support and application development
• Comprehensive knowledge of the legal & regulatory requirements and standards regarding pharmacovigilance
• Knowledge with Drug Safety or Clinical IT systems regarding system management and configuration, knowledge in Oracle Argus Safety is preferred
• Comprehensive knowledge in database programming using SQL and PL/SQL
• Experience with business intelligence applications like Business Objects or comparable tools and in computer system validation under GxP regulations
• Excellent English skills (both orally and in writing) and good communication skills in order to transfer business requirements into technical solutions
• Process excellence, proactiveness, customer focused mindset
• Flexibility in adapting to changing needs and priorities
• Efficient team working attitude and good presentation skills