🔍 Consultant Drug Safety (Portuguese)

📍 Location: Hybrid
🕓 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

• Project managing:
• Acting as the primary contact point for project-related matters for the client and internally.
• Maintaining good client relations and ensuring a consistently high quality of work.
• Preparing project scope and objectives based on signed agreement between the client and QbD Group.
• Project activity planning, including meeting deadlines and interim milestones
• Reporting for the client and QbD Group management e.g. preparation of Monthly reports, serving as basis for invoicing.
• Develop and review Pharmacovigilance Standard Operating Procedures (SOPs/WI) for clients.
• Cases management control:
• Data entry and quality control of PV cases in post-marketing and clinical trials, or related to medicinal products, medical devices and cosmetics.
• PV Assessment of any case of suspected adverse reaction.
• Direct contact with HCP and patients/consumers.
• Perform any follow-up activities required.
• Submission of cases to Eudravigilance, MHRA or any other Competent Authority.
• Perform bibliographic research in local scientific journals, international journals, MLM service and any other type of search.
• Management of medical information and answering queries.
• Review and control of Safety Regulatory intelligence
• Review and control of Pharmacovigilance agreements
• Review and control of Pharmacovigilance quality system
• Support in PV audits and inspections of clients
• Pharmacovigilance training
• Perform and manage PV metrics and KPIs linked to projects in charge.
• Participation in preparation of PV aggregate reports under supervision of Senior Drug Safety Officer)
• Client Support in Pharmacovigilance inspections and audits for services provided.
• Elaboration, follow-up and evaluation of the CAPA plan applicable to the project.

💪 What you bring

• Bachelor's degree in Life Sciences or related. Must
• Master's degree in Pharmacovigilance, Pharmaceutical Industry or related. Desirable.
• High level of English. Must.
• High level of portuguese. B2 Must.
• Advanced informatic skills - knowledge of MS Office. Desirable.
• Experience in project management. Desirable
• Knowledge of Good European Pharmacovigilance Practices (GVPs)
• At least 3 years of experience in Pharmacovigilance, having been involved in: cases management and signal detection
• Quality knowledge regarding the management of deviations / CAPAs. Desirable
• Knowledge regarding Eudravigilance requirements for Marketing Authorization Holders (clients) and the processes with the Health Competent Authorities. Desirable.
• Experience in Pharmacovigilance audits. Desirable

🫵 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. You could be the next one to join the QbD family.