Safety Physician

Agomab Therapeutics; Antwerpen; Hybrid; EUR 120,000 - 180,000; Full time

Job summary

Agomab Therapeutics is seeking a hands-on Safety Physician to strengthen our Drug Safety and PV capabilities across a 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,

Qualifications

• MD with ≥5 years in biotech/pharma PV.
• Experience drafting safety content for regulatory submissions.
• Strategic, independent, and cross-functional collaboration.
• Strong organization and communication in fast-paced env.
• Fluency in English; additional languages appreciated.

Responsibilities

• Create and maintain Reference Safety Information.
• Review safety data to identify, evaluate and minimise risks.
• Provide medical safety input to protocols, brochures, clinical study reports and regulatory submissions.
• Review and validate clinical-study ICSR and ensure expedited reporting.
• Oversee Safety Management Plans and outsourced PV activities.
• Chair Safety Review Team meetings and ensure timely signal evaluation.
• Support publications and medical information materials.
• Strengthen the PV quality system via SOPs, audits and inspections.
• Take on broader strategic and leadership responsibilities as the function grows.

Skills

Drug Safety & PV experience

Regulatory submissions input

Strategic leadership

Fluent English

Education

MD degree

Job 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 ICSR, 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.