Safety Evaluation and Risk Manager
Budapest Hungary (Hybrid)
Contract role Qualification: MBBS/ MD
Experience: Min 3 years’ experience in signal management, safety report authoring and reviewing,
Benefit Risk management plan.
Job Responsibilities:
Safety Governance and Risk Management activities
1. Conducts, or leads with guidance, pharmacovigilance and risk management planning for
designated products.
2. Contributes to regulatory benefit-risk assessments and prepares the regional Risk Management
Plans for designated products In partnership with the product scientist, provides clinical safety
input into Clinical Development planning activities
3. Provides input on cross-functional ad-hoc teams set up to address urgent and important safety
issues.
4. Reviews and provides technical approval for investigator brochures, protocols, Informed
consents, final study reports and external data monitoring committee charters. May present
safety inform...