Senior Safety Physician, PV Lead – Remote Options

Agomab Therapeutics; Antwerpen; Hybrid; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

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,

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Drug Safety & PV experience

Regulatory submissions input

Strategic leadership

Fluent English

Ausbildung

MD degree

Jobbeschreibung

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,