- Location
- Antwerpen, Antwerp
- Workplace
- Hybrid
- Type
- Full-time
- Department
- Healthcare
- Education
- Master
- Source
- Pinpoint
Description
Safety Physician
Department: Clinical Development
Employment Type: Permanent - Full Time
Location: Agomab Antwerp
Description
We are looking for a hands-on Safety Physician to strengthen our Drug Safety and Pharmacovigilance (PV) capabilities across our small-molecule portfolio. Reporting to the Head of PV, you will guide programmes from early development through proof of concept and beyond, initially as a key individual contributor with scope to take on broader leadership responsibilities.
You will oversee safety data review, ICSR quality, signal management, benefit–risk evaluation and medical review of safety documents, helping shape the strategy for our organ-restricted therapies and late-stage ambitions.
Key Responsibilities
- Create and maintain Reference Safety Information for assigned compounds.
- Review safety data to identify, evaluate and minimise emerging risks.
- Provide medical safety input to protocols, investigator’s brochures, clinical study reports, development plans and regulatory submissions.
- Review and validate clinical-study ICSRs, working with the PV service provider to meet expedited reporting requirements.
- Review study Safety Management Plans and oversee outsourced PV activities.
- Chair Safety Review Team meetings and ensure timely signal evaluation.
- Support publications and medical information materials.
- Strengthen the PV quality system through SOPs, audits, inspections, regulatory intelligence and process improvement.
- Take on broader strategic and leadership responsibilities as the function grows.
Skills, Knowledge and Expertise
- MD degree and at least five years’ Drug Safety and PV experience in the biotechnology or pharmaceutical industry.
- Experience developing and reviewing medical safety content for regulatory submissions, including NDAs, EU MAAs and health-authority responses.
- A strategic, hands-on approach, with the ability to work independently, collaborate across functions and mentor others as the team grows.
- Strong organisational, project-management and communication skills in a fast-paced environment.
- Fluent English; additional languages are an advantage.
What we offer
- A high-impact role shaping PV in an ambitious, innovation-driven biotech company.
- Direct involvement in pioneering therapies for unmet medical needs.
- A collaborative, agile and fast-paced environment.
- A role based in Antwerp, Belgium, with remote-working options tailored to your needs.
- Competitive salary and benefits.