21 oct
|
TRIUM Clinical Consulting
|
Pozuelo de Alarcón
21 oct
TRIUM Clinical Consulting
Pozuelo de Alarcón
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 integral 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
📌 Consultant Medical Information (Pozuelo de Alarcón)
🏢 TRIUM Clinical Consulting
📍 Pozuelo de Alarcón