Consultant Medical Information (España)

Consultant Medical Information (España)

22 oct
|
Qb D Group
|
España

22 oct

Qb D Group

España

Consultant Medical Information - German Location: Hybrid / Madrid Type: Full-time The Qb D Group supports life sciences companies worldwide from idea to patient.
Qb D's team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in ATMP, Biotech, Medical Devices, In Vitro Diagnostics, Digital Health and Pharma.
Qb D has affiliates in 8 different countries and can count on the expertise of more than 500 life science professionals and growing.
What's in it for you Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices Grow within a community of experts: Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise.
Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations — because your contribution deserves to be valued.
What you'll be doing General Responsibilities: Assume the responsibilities of Information Officer, a mandatory role in Germany.
Carry out activities specific to the area, including the execution of assigned projects and direct interlocution with clients, ensuring high-quality delivery and client satisfaction.
Act as a reliable scientific partner to clients, demonstrating a strong understanding of their needs, therapeutic areas,



product portfolios and regulatory environment Collaborate with different organizational levels to improve existing processes and drive continuous operational excellence.
Support and ensure compliance with the Quality Management System (QMS) within their area of responsibility.
Collaborate in the planning, coordination and execution of activities required to achieve department and client objectives.
Actively participate in audits and inspections related to Medical Information and Pharmacovigilance activities.
Support digital transformation initiatives, including the evaluation and implementation of AI-based tools to enhance literature screening, data analysis and workflow efficiency.
Foster cross-functional collaboration with Pharmacovigilance, Regulatory Affairs, Clinical, and other relevant departments if needed.
Medical Information: Handle Medical Informationl Enquiries, Adverse Events and Product quality complaints received via call center or email.
Carry out activities specific to Medical Information services including Q&A; preparation, standard response letters, full-text article provision and scientific/medical communication.
Collaborate with the Medical Information call center operations, including activities integrated within Patient Support Programs (PSPs), ensuring proper safety data collection, documentation and reconciliation with Pharmacovigilance Support Medical Information training activities and knowledge sharing within the team.




Perform Promotional and non-promotional material review from a scientific/medical perspective Pharmacovigilance: Conduct general and local bibliographic searches, European Agency searches, authority searches and safety literature monitoring in compliance with GVP requirements.
Participate in Regulatory Pharmacovigilance Intelligence activities, including monitoring and interpretation of regulatory updates, health authority alerts, safety trends and emerging risks.
Specific Responsibilities: Perform assigned Quality activities within the area (deviations, CAPAs, change controls), supporting timely resolution and compliance with QMS requirements.
Review and adapt Qb D Group SOPs and working instructions to ensure alignment with client-specific procedures and regulatory requirements.
Contribute to the definition and monitoring of Medical Information metrics and KPIs, supporting performance tracking and continuous improvement.
Participate in internal and external MI training activities, including onboarding, continuous development and PSP-related training.
Support project coordination for assigned clients across delegated Medical Information, Medical Enquiries, PSP call center and Pharmacovigilance Intelligence activities, collaborating with internal and external resources as required.
Create, validate and maintain automated search alerts tailored to each client's product portfolio and therapeutic area.
Perform weekly review, documentation and reporting.
Perform searches within European Medicines Agency (EMA) databases, including: Application of Qb D Group-defined filters (MLM) Download and reconciliation of ICSRs when applicable L2 A case downloads Conduct Authority Searches by reviewing Regulatory Ag

📌 Consultant Medical Information (España)
🏢 Qb D Group
📍 España

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