Safety Physician

Agomab

. Create and maintain Reference Safety Information for assigned compounds.

Posted 10/27/2026full-timeAntwerp • BelgiumMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Drug Safety and Pharmacovigilance, with a strong focus on developing and reviewing medical safety content for regulatory submissions. Proven ability to lead cross-functional collaborations and mentor team members while ensuring compliance and quality in safety management.

Highest-signal resume keywords

MD DegreeDrug Safety ExperiencePharmacovigilance ExperienceRegulatory Submissions ExpertiseProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Reference Safety Information CreationSafety Data ReviewClinical Study Report DevelopmentICSR ValidationSignal Evaluation

Soft Skills

Strong Organisational SkillsEffective Communication SkillsCollaboration SkillsMentoring Skills

Tools & Technologies

Safety Management PlansSOPsAuditsRegulatory Intelligence

Industry Keywords

BiotechnologyPharmaceutical IndustryNDAEU MAAHealth-Authority Responses

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

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.