Senior Specialist, Regulatory & PV Network

📋 Description

• Act as Local Contact Person for Pharmacovigilance for the designated country
• Lead regulatory deliverables and PV activities per plan, coordinating with internal and external
• Develop strategy and manage set up activities (PM Plan, procedures, POAs, core documents)
• Provide input to budgets, client invoices, and vendor management
• Mentor junior staff and foster internal/external collaborations
• Stay updated on regulatory changes and support audits/inspections as needed

🎯 Requirements

• Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent
• Experience in pharmaceutical/CRO or regulatory bodies
• Knowledge of ICH GCP/GVP and national regulations for territories of competency
• PV training/experience and relevant local qualifications
• Fluent in English; proficiency in local official language where based
• Strong planning, organizational, and communication skills

🎁 Benefits

• Global pharmacovigilance environment with patient safety focus
• Collaborative team across Europe, North America, and beyond
• Professional development and growth opportunities