Ergomed

• Supporting the Systems Engineering team in the development, testing and maintenance of internal applications and services. • Collaborating with project managers, business units and the Systems Engineering team to deliver new features, improvements, troubleshooting and debugging of issues. • Writing clean, maintainable, test-driven and well-documented code following team standards and best practices. • Contribute to testing, documentation and challenging development processes for continuous development. • Provide technical support for systems within the Systems Engineering remit.

• The Clinical Team Manager will be responsible for operational project management • The CTM proactively identifies, resolves/mitigates, and escalates risks and/or issues to the PM/PD and Head of Clinical Operations as necessary • Verifying and ensuring that project team members (CRAs, Site Managers, CTAs) are trained (e.g., GCP, SOP, indication, protocol, study specific procedures / requirements, etc.) to perform their assignments • Developing, reviewing and revision of project documents (e.g., clinical monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.) • Initiating corrective / preventative measures – e.g., update of study guidance documents, performing re-training, performing co-monitoring, etc.

• Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study • Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conduct the clinical study throughout the study period. • Trains investigational site staff as necessary • When applicable, supports preparation of regulatory and / or EC submissions • Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance.

Role Description The Medical Information (MI) Officer is a senior member of the MI Department. The role is ideal for a confident and enthusiastic individual with experience in Medical Information and Medical Affairs. In addition to MI enquiry handling, they assist in team management, project management, complex MI response development, and process improvement within the MI Department. The role supports the delivery of high-quality Medical Information services. Proven experience in mentoring team members and a strong track record in direct Line Management. As this is a fully home-based position, the successful candidate must have a dedicated, private home office space (separate from shared communal areas) and a high-speed, reliable broadband connection to ensure data privacy and seamless connectivity. - Manage day-to-day project-related expectations based on agreed scope of work with client. - Provide project management support/training to junior staff and provide regular updates regarding project status to management. - Take responsibility for handling complex medical information enquiries via calls and emails including second line responses for more complex enquiries where a literature search is required. - Accurately identify, document and report adverse events/side effects, pregnancy and other special situation events, and product quality complaints in a clear and concise manner within required timeframes. - Participate in the out-of-hours provision of medical information for clients who have contracted a 24/7 enquiry handling service. - Providing management with regular updates regarding project status and metrics concerning enquiries. - Assisting in departmental inspection preparedness for the company pharmacovigilance system and actively participating in PV and MI inspections or audits. - Responsible for the quality check process for the MI team. Qualifications - Life Science / Healthcare professional degree e.g. Nursing, Pharmacist. - Relevant experience in medical information or related fields. - English - advanced (spoken, written). - Preferred experience in project management within a call centre setting. Benefits - Training and career development opportunities internally. - Strong emphasis on personal and professional growth. - Friendly, supportive working environment. - Opportunity to work with colleagues based all over the world, with English as the company language.

• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps. • Reconciliation activities for all types of received reports

• Collaborate with subject matter experts across geographies • Create and update learning materials • Publish courses on our LMS • Gather feedback and contribute to the continuous improvement of our training programs • Design and develop training materials aligned with business objectives, applying instructional design models and adult learning principles • Create interactive, scenario-based content, original learning materials, and assessments in partnership with SMEs across the organization • Manage multiple concurrent People Development projects, working with internal stakeholders and external technology partners to implement training priorities on time and to standard • Gather feedback and evaluating training effectiveness using frameworks such as Kirkpatrick to inform continuous improvement of programs

• Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study • Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conduct the clinical study throughout the study period • Trains investigational site staff as necessary • When applicable, supports preparation of regulatory and / or EC submissions • Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance.

Role Description Ergomed is looking for an eLearning Specialist to join our team and support the design and delivery of learning solutions that drive business performance in an international environment. You will collaborate with subject matter experts across geographies, create and update learning materials, publish courses on our LMS, gather feedback, and contribute to the continuous improvement of our training programs. While the main priority will be developing the structure and content of training materials tailored to business needs, the role also extends to broader People Development projects, including: - Supporting onboarding and capability-building programs - Contributing to learning strategy, communications, and culture initiatives across the organization Key responsibilities include: - Designing and developing training materials aligned with business objectives, applying instructional design models (e.g., ADDIE, SAM) and adult learning principles - Creating interactive, scenario-based content, original learning materials, and assessments in partnership with SMEs across the organization - Publishing, maintaining, and quality-checking courses on Cornerstone LMS, ensuring alignment with brand standards, accessibility, and learner experience - Managing multiple concurrent People Development projects, working with internal stakeholders and external technology partners to implement training priorities on time and to standard - Gathering feedback and evaluating training effectiveness using frameworks such as Kirkpatrick to inform continuous improvement of programs Qualifications - Bachelor's degree or equivalent practical experience - 2-3 years of experience developing and delivering training content, with hands-on expertise in Articulate Rise and Storyline - Excellent English (written and spoken) and confidence working in an international, cross-cultural environment - Strong ability to structure material, write scripts, and design interactive content, presentations, and job aids, grounded in instructional design, andragogy, and business learning principles - Demonstrated ability to translate complex content from SMEs into clear, engaging learning experiences - Systems thinking, attention to detail, accountability for results, and the ability to work with internal stakeholders and consistently meet deadlines - Flexibility, self-direction, and strong communication skills, with the ability to interview SMEs and collaborate within cross-functional teams Requirements - Proficiency in Canva or similar design tools (e.g., Figma, Adobe Express, etc) - Experience leveraging AI tools (e.g. Claude, Synthesia) to accelerate content development, generate drafts, or create multimedia learning assets - Previous experience in the pharmaceutical, biotech, pharmacovigilance, CRO, or broader life sciences industry would be a strong plus - Familiarity with LMS and authoring tool integration (SCORM, xAPI), ideally with hands-on experience in Cornerstone or systems of comparable complexity - A portfolio or work samples demonstrating instructional design and content creation capability is highly desirable Benefits - A supportive and dynamic work environment with helpful colleagues - Opportunities for continuous learning and career advancement - Flexibility in working arrangements, including the possibility of remote work - Recognition and appreciation of your contributions and achievements

• Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader and Line Manages ICSR staff • Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process • Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management • Contributes to achieving company´s goals and objectives • Works under supervision of ICSR Operational Lead • Providing support to other activities undertaken by the project team on behalf of the client and the company • Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency) • Proposes process changes to ICSR Operational Lead • Manages ICSR deviations with ICSR Operational Lead support • Reviews trackers and timesheet data and ensures accuracy • Is involved in ICSR processing and 2nd QC of cases • Support other departments, as approved and instructed by ICSR Operational Lead • Operates as the assigned team SME • Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

• Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader and Line Manages ICSR staff • Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process • Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management • Contributes to achieving company´s goals and objectives • Works under supervision of ICSR Operational Lead • Providing support to other activities undertaken by the project team on behalf of the client and the company • Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency) • Proposes process changes to ICSR Operational Lead • Manages ICSR deviations with ICSR Operational Lead support • Reviews trackers and timesheet data and ensures accuracy • Is involved in ICSR processing and 2nd QC of cases • Support other departments, as approved and instructed by ICSR Operational Lead • Operates as the assigned team SME • Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager