AstraZeneca
Pharmaceutical
SeniorPatientSafetySpecialist
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Patient Safety Specialist at AstraZeneca. Skills: Patient Safety activities, Local regulations, Health Authorities communication. Maintain knowledge of local regulations. Upgrade knowledge of internal procedures”
Industry & Context.
Autonomous problem solving
Some travel (max. up to 40%)
What They're Looking For.
Must Have
University Degree in Medicine, University Degree in Pharmacy, University Degree in Stomatology, Work experience in Pharmaceutical Industry, Fluent English, Fluent Serbian
Nice to Have
Patient Safety experience, Experience with multiple non-EU Balkan markets, AI embrace
What You'll Do.
Maintain knowledge of local regulations
Upgrade knowledge of internal procedures
Communicate requirements to other teams
Perform Licence To Operate activities
Provide cross functional support
Oversight of safety-related processes
Oversight of safety issues
Oversight of brand activities
Plan Safety Submissions
Coordinate Safety Submissions
Submit Safety Submissions
Follow up Safety Submissions
Coordinate responses to HA queries
Implement Risk Minimization Plan
How You'll Work.
Team & Collaboration
Cross functional support; Cross functional working relationships
Full Job Description
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 now looking for a **Senior Patient Safety Specialist** to perform Patient Safety activities in line with AZ policies and local regulations of Serbia and associated non-EU Balkan markets. **Main tasks and responsibilities:** * Maintaining and upgrading in depth knowledge of actual local regulations and internal procedures, as well as changes to them, and understanding their mutual linkage and impact to working processes, communication of requirements to other teams within market and globally * Planning and performing Licence To Operate activies and cross functional support to other AZ teams, such as maintenance and oversight of all safety-related processes, issues, and brand activities within assigned markets, safety exchange and/or communication with Health Authorities in assigned markets - planning, coordination, submission, follow up of Safety Submissions (aggregate safety reports, RMPs, Signals, ICSRs), coordination of responses to HA queries in assigned markets in line with local regulations and internal company procedures, Risk Minimization Plan and aRMMs implementation, PSMF maintenance and PharmacoVigilance Agreements **Your Profile:** * University Degree in Medicine, Pharmacy or Stomatology. * Work experience in Pharmaceutical Industry within Patient Safety (preferably with multiple non-EU Balkan markets). * Advanced knowledge of office PC applications (Word, SharePoint, Excel), ready to embrace power of AI * Proven ability to use Initiative - engaging in proactive behaviour. * Experience of working in cross-functional framework * Autonomous problem solving skills, focus on delivery and result. * Interpersonal and networking skills, ability to develop good cross functional working relationships and to work as part of a team. * Ethical mi
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