Descripción de la oferta
Senior Consultant Medical InformationLocation : HybridType : Full-timeThe 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 devicesGrow 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 doingGeneral Responsibilities:To carry out activities specific to the area that include the management of assigned projects or direct interlocution with clients.Provide direct support to the area manager in decision making regarding proposal review, business area expenses and resource allocation.Identification of training needs and development opportunities for department staff.Collaboration with lower organizational levels in the improvement of existing processes.Support with the Quality Management System as it relates to their area of work and competencies.Collaborate in the planning, coordination and execution of tasks to achieve the objectives set.Participation in audits and inspections related to their area of work.Deep understanding of the needs of each client.Elaboration of bids.Local and international bibliographic searches.European Agency Searches.Authority Searches.Medical Information, MI queries, Q&A, full text articles request, promotional and non‐promotional material review, scientific/medical bibliographic searches control and coordination.Medical Department vendor support to develop the Medical/Marketing Brand Plan.Pharmacovigilance literature monitoring, control and report.Pharmacovigilance/Medical Information call center.Pharmacovigilance and Medical information Project Management for different clients.Provides suggestions on business and operational decisions that affect the department.Student mentoring and training.RRAA and PV Collaboration.MI Director business support.Coordination and team management.External/internal training tasks.Specific Responsibilities:Review and manage the Quality activities (deviations / CAPAs).Review QbD Group's SOPs to verify that they are adapted to the client's requirements when applicable.Perform and manage MI metrics and KPIs.Manage internal and external MI training.Project manager for different clients, controlling all the delegated MI activities (at internal and external level).Local searches; review of local journals agreed with each client; review of security and cases related to the active principles of each company; record of results to maintain traceability and shipment to client on date.International research in Pubmed, Reactions Weekly.Creation of alerts depending on each company and the active ingredients and medicines they apply; weekly review of alerts and recording of results for subsequent dispatch to client on date.Searches in the European Agency.MLM Application of filters created in QbD Group for each company and download of cases at the EMA Registration of results and sending them to the client as long as it applies.L2A downloading of cases at the EMA by companies Registration of results and communication to the client.Authority Searches.Review of the Regulatory Agencies pages to find health alerts, variations in technical specifications or any other relevant information of the active principles of the different companies.Monthly special situation searches excluded from the searches at the EMA.Medical Information, MI queries, Q&A, full text articles request, promotional and non‐promotional material review, scientific/medical bibliographic searches, call center, standard letters and other MI activities.MI information and activities control and management.Pharmacovigiliance literature monitoring, control and report.Pharmacovigilance/Medical Information call center.Pharmacovigilance/Medical information Project Management for different clients (Searches activities).Provides suggestions on business and operational decisions that affect the department.Collaborate with PV Senior/Junior officers with the PV literature monitoring process, product list update, reconciliation and notification process.Collaborate with RRAA Senior/Junior Consultants with the Promotional Material review and validation from a Scientific/Medical point of view.Collaborate with Clinical trials, Toxicology, Medical Devices, Cosmetic products, Veterinarian, PV, RRAA etc. QbD Group Consultants to provide requested Scientific/Medical information and/or literature.Provide support to the MI Director and assist with review proposals, costing for MI Business and distribution resources.Mentoring, training and coordination of the Medical information Trainees.What you bringRequired:Bachelor's degree in Life Sciences or related.Master's degree in Pharmaceutical Industry or related. Desirable.PhD in life sciences is a plus.Knowledge and management of scientific databases (Pubmed, Medline, Clinicaltrials.gov, Medes, Fisterra, Cochrane).High level of English.Advanced informatic skills.Competent in office and data analysis packages.Previous experience:Previous experience in the Pharmaceutical Industry (Medical Affairs, Regulatory Affair, Medical Marketing and/or Pharmacovigilance Departments) showing an aligned criteria to develop the Medical Brand Plan and its implementation.Proven Scientific/Medical Background (+5 years) 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 a strategic mindset to understand and work aligned with the Company Business Plan.Experience leading teams is a plus.Personal skills:Proactive, analytical, and pragmatic approach to problem-solving. Able to work under pressure, juggling short deadlines, multiple priorities.Good teamwork skills and demonstrated leadership along with the ability to work well with professionals at all levels and roles of the organization.Attention to detail and analytical skills.Extended experience in the writing of scientific texts.Organization ability and task prioritization.Empathy and flexibility to deal with clients and partners.Client and results oriented.Who you areOur 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 usWe 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.#J-18808-Ljbffr
