Consultant Medical Information - German
hace 10 horas
Madrid
Consultant Medical Information - German Revise detenidamente toda la documentación de la solicitud antes de hacer clic en el botón de solicitar al final de esta descripción. 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. #J-18808-Ljbffr
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