Consultant Drug Safety
📍 Location: Warsaw – hybrid work
🕓 Type: Full-time
🏢 What you’ll be doing
Participation in the development and maintenance of the SciencePharma quality system and Clients’ quality systems in the area of pharmacovigilance.
Design and implementation of procedures (SOPs), instructions (INS), annexes, and other types of system documentation.
Participation in or organization of risk analyses related to pharmacovigilance processes, including preparation of relevant system documentation.
Preparation and/or review of the detailed description of the medicinal product adverse event monitoring system (PSMF).
Preparation or update of Safety Data Exchange Agreements (SDEA) with SciencePharma Partners or Clients.
Participation in or leadership of pharmacovigilance audits, including preparation of appropriate system documentation for this process (e.g. agenda, questionnaires, audit reports). Participation in pharmacovigilance inspections.
Supervision and coordination of activities related to onboarding or offboarding a Client or their product(s) into/from the SciencePharma Pharmacovigilance system.
Cooperation with Clients for whom SciencePharma provides local pharmacovigilance services (local PV point) in Poland.
Communication with Clients, including clear and precise information sharing, identification and ongoing management of Client needs, and ensuring a high standard of daily cooperation.
💪 What you bring
Education in pharmacy, life sciences, or quality management.
Experience in preparing system SOPs and INS documents.
Experience in conducting quality system and/or pharmacovigilance audits.
Experience in direct communication with Clients.
Good command of medical English, both written and spoken.
Willingness to develop knowledge of pharmacovigilance in a broader context (cooperation with other PV team members involved in case processing, system-related tasks, and medical writing.
Good knowledge and practical use of MS Office tools.
Nice to have
Experience in the medical devices area.
Experience in preparation and/or update of PSMF.
Experience in preparation and/or update of SDEA agreements.
💡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 comprehensive benefits package: You will have access to private medical care, a flexible benefits cafeteria including a sports card, group life insurance, and an employee referral program.
🫵 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.
- Dział
- Vigilance
- Rola
- Drug Safety
- Lokalizacje
- QbD Poland
- Tryb pracy
- Hybrydowo