Consultant Medical Information - German
Consultant Medical Information - German
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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, , Medes, Fisterra, Cochrane)
- Languages: High level of German and English or Spanish
- Desiderable additional languages: French, Spanish
Who you are
- 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. xcskxlj
You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger.
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