Senior Consultant Medical Information
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Job Location:
Pozuelo de Alarcón - Spain
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Senior Consultant Medical Information
Location: Hybrid
Type: Full-time
The QbD Group supports life sciences companies worldwide from idea to patient. QbDs team offersknowledge&tailored (software) solutionsin development clinical regulatory & compliance production and distribution for companies active inATMP 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.
Whats 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 youll be doing
General 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 Groups SOPs to verify that are adapted to the clients requirements when they are 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. 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 Scientifical/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 bring
Required:
Bachelors degree in Life Sciences or related.
Masters degree in Pharmaceutical Industry or related. Desirable.
PhD in life sciences is a plus.
Knowledge and management of scientific databases (Pubmed Medline 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 and 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 are
Our culture is driven by values If this sounds like you youll fit right in:
Youre resilient and tackle challenges with a positive mindset
Youre curious and always up for learning something new
You have a no non-sense approach honest clear respectful
Youre innovative and bring ideas not just opinions
And above all youre 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 wont just be taking a job youll be joining a community where people grow laugh build and contribute to something bigger.
Interested Lets talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.
