Patient Safety Senior Specialist

Responsibilities

• Maintain and upgrade in-depth knowledge of local regulations and internal procedures for Serbia and associated non-EU Balkan markets.
• Plan and perform License To Operate activities, including the maintenance and oversight of safety-related processes and brand activities.
• Coordinate safety exchange and communication with Health Authorities in assigned markets.
• Manage the planning, coordination, submission, and follow-up of Safety Submissions, including aggregate safety reports, RMPs, Signals, and ICSRs.
• Coordinate responses to Health Authority queries in line with local regulations and internal company procedures.
• Implement Risk Minimization Plans (RMPs) and aRMMs, and maintain the Pharmacovigilance System Master File (PSMF) and Pharmacovigilance Agreements.

Requirements

• University Degree in Medicine, Pharmacy, or Stomatology.
• Minimum of 2 years of pharmaceutical industry experience specifically within Patient Safety.
• Proven experience working with multiple non-EU Balkan markets.
• Advanced proficiency in MS Office applications (Word, SharePoint, Excel).
• Fluent English communication skills.
• Strong interpersonal, networking, and cross-functional collaboration skills.
• Ability to work autonomously with a focus on problem-solving and results.
• High attention to detail and an ethical mindset.

About the Company

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. We are dedicated to being a phenomenal place to work, where employees are empowered to push the boundaries of science and ignite their ambitious spirit.