Consultant Drug Safety Pharma & MD

Consultant Drug Safety - Pharma & MD

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.

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

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

• 25 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

• English is a Must

• German is a Plus

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 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.