Consultant Medical Information - German

Consultant Medical Information - German

Location: Hybrid / Madrid
Type: Full-time

The QbD Group supports life sciences companies worldwide from idea to patient. QbD'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.
QbD 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 global 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 QbD 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 QbD Group-defined filters (MLM)
• Download and reconciliation of ICSRs when applicable
• L2A case downloads
• Conduct Authority Searches by reviewing Regulatory Agency websites to identify health alerts, safety communications, variations in product information, and other relevant regulatory updates.
• Perform monthly special situation searches not captured via EMA databases.
• Ensure proper identification, documentation and reconciliation of safety information arising from MI queries and PSP interactions in collaboration with Pharmacovigilance.
• Collaborate with Pharmacovigilance literature monitoring processes, including case identification, tracking, reconciliation and reporting.
• Participate in Regulatory Pharmacovigilance Intelligence activities, analysing emerging safety data and regulatory trends.
• Evaluate and support the implementation of AI-based tools and digital solutions to optimise literature screening, case identification and MI workflow efficiency.
• Provide operational recommendations to support continuous improvement of departmental processes and client service delivery.
• Collaborate with PV Senior/Junior Officers in literature monitoring, product list updates, reconciliation and safety notification processes.
• Collaborate with Regulatory Affairs Consultants in the scientific/medical review and validation of promotional materials.
• Collaborate cross-functionally with other company departments such as Clinical Trials, Toxicology, Medical Devices, Cosmetics, Veterinary, PV and RA teams to provide scientific/medical expertise and literature support.
• Support onboarding, training and knowledge sharing for Medical Information trainees and junior consultants.

Who you are

Education

• Bachelor's degree in Life Sciences or related.
• Master's degree in Pharmaceutical Industry or related. Desirable.
• PhD in life sciences is a plus.

Experience

• Previous experience in the Pharmaceutical Industry (Medical Affairs, Regulatory Affair, Medical Marketing, Medical Information and/or Pharmacovigilance Departments) showing an aligned criteria to develop the Medical Brand Plan and its implementation.
• Proven Scientific/Medical Background based on Scientific/Medical Research on Academia or Industry, with a strong background and experience in medical and scientific literature management and interpretation, scientific/medical content communication, and scientific strategic mind.
• Clinical, therapeutical and/or clinical trials knowledge included the life cycle of a drug to correctly interpret the scientific and medical literature (clinical trials results, interventional and non-interventional trials, meta-analysis, mechanism of action, safety, etc.) and provide and strategic mindset to understand and work aligned with the Company Business Plan.

Technical skills:

• Knowledge and management of scientific databases (Pubmed, Medline, Clinicaltrials.gov , Medes, Fisterra, Cochrane)
• Languages: High level of German and English or Spanish
• Desiderable additional languages: French, Spanish

Who you are

Our culture is driven by values If this sounds like you, you'll fit right in:

• You're resilient and tackle challenges with a positive mindset
• You're curious and always up for learning something new
• You have a no non-sense approach honest, clear, respectful
• You're innovative and bring ideas, not just opinions
• And above all, you're serious about your work, but not too serious about yourself

About us

We support life sciences companies from idea to patient - offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma.

We believe in JPEG:
Joy. Partnership. Going the Extra Mile. Getting Things Done.

You won't just be taking a job - you'll be joining a community where people grow, laugh, build, and contribute to something bigger.

Interested? Let's talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.

Service Vigilance Role Medical information Locations QbD Spain (Madrid)