Associate Director Patient Safety Romania
Core
Lead country-level patient safety strategy and execution for AstraZeneca in Romania, ensuring compliance with local regulations and global standards while managing risk and safety activities.
Role type
Senior IC/Manager Patient Safety Director (Pharmacovigilance)
Builds
Local patient safety operations, regulatory compliance, and risk management plans for prescription medicines
Domain
Biopharmaceuticals / Pharmacovigilance / Healthcare Regulation
Deliverable
client delivery
Required skills
Pharmacovigilance expertise, Good Pharmacovigilance Practice (GVP) knowledge, health authority regulation expertise, cross-functional collaboration, project management, vendor management, audit and inspection experience, change management, root cause analysis, CAPA implementation
Preferred skills
Advanced scientific degree, medical affairs knowledge, clinical research understanding, commercial operations insight, medical marketing experience, conflict resolution
Technologies
Pharmacovigilance systems, PSMF, Risk Management Plans (RMP), Organised Data Collection Programmes
Responsibilities
Act as national contact person for pharmacovigilance; maintain local procedural documents and PSMF accuracy; lead Health Authority interactions and queries; support safety management agreements and clinical study protocols; manage PV aspects of digital/social media and external collaborations; support audit and inspection processes; implement corrective and preventative actions for non-compliance
Seniority
Senior, managerial leadership with technical expertise
