Consultant Drug Safety - Pharma & MD
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Location : Hybrid - Madrid
Type : Full-time
At
QbD Group, we support life sciences companies worldwide
from idea to patient. Our teams provide expertise and tailored solutions across development, clinical, regulatory, quality and compliance for companies active in
Pharma, Biotech, Medical Devices, IVD and Digital Health .
With more than
500 life sciences professionals across Europe, we work as a strategic partner helping our clients navigate complex regulatory environments and ensure patient safety.
To strengthen our
Vigilance Division, we are looking for a
Consultant in Pharmacovigilance and Medical Device Vigilance
to support international projects for pharmaceutical and medical device companies.
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
As a
Consultant Vigilance, you will support our clients in ensuring compliance with
Pharmacovigilance and Medical Device vigilance regulations, contributing to the safety monitoring of medicinal products and medical devices throughout their lifecycle.
You will work in a
dynamic consulting environment, collaborating with multidisciplinary teams across different countries and supporting both
pharmaceutical and medical device manufacturers .
Key Responsibilities
Pharmacovigilance activities
Management and review of
Individual Case Safety Reports (ICSRs)
Preparation and review of
Aggregate Safety Reports :
PSUR / PBRER
DSUR
Risk Management Plans (RMPs)
Signal detection activities and safety data analysis
Literature monitoring and safety information management
Support in
Pharmacovigilance System Master File (PSMF)
preparation and maintenance
Development and review of
SOPs, WIs and Pharmacovigilance agreements (SDEAs)
Support in
PV audits, inspections and CAPA management
Medical Device Vigilance & Post-Market Surveillance
Support
Post-Market Surveillance (PMS) activities
according to EU MDR
Preparation and review of:
PMS Reports
PSUR for Medical Devices
Management of
incidents and serious incidents
Support
trend reporting and signal/trend analysis
Contribution to
Field Safety Corrective Actions (FSCA)
Support activities related to
EUDAMED
Contribution to vigilance system documentation and regulatory compliance
Consulting & Client Support
Support clients in implementing
robust vigilance systems
Participate in
regulatory gap assessments and process improvements
Contribute to
project management and client communication
Prepare
KPIs, metrics and project reports
Collaborate with cross-functional teams in
Regulatory Affairs, QA and Clinical
What you bring
Education
Degree in
Life Sciences, Pharmacy, Biotechnology or related field
Experience
2–5 years of experience
in:
Pharmacovigilance and/or
Medical Device Vigilance / Post-Market Surveillance
Technical knowledge
Knowledge of
EU Good Pharmacovigilance Practices (GVP)
Knowledge of
EU Medical Device Regulation (MDR) vigilance requirements
Experience with:
PMS / PSUR for Medical Devices
Incident reporting
Safety reports
Familiarity with
EudraVigilance and/or EUDAMED
is an asset
Skills
Strong analytical and problem-solving skills
Ability to work in an
international consulting environment
Good organizational and project management abilities
Strong written communication skills
Attention to detail and quality mindset
Team player with a proactive attitude
Who you are
Our 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 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 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. xpzdshu You could be the next one to join the QbD family.
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