AstraZeneca
Biopharmaceutical
SeniorSpecialistPatientSafety
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Specialist Patient Safety at AstraZeneca. Skills: Patient Safety, Pharmacovigilance, GVP compliance. Maintain oversight of safety-related processes. Process ICSRs”
Industry & Context.
What They're Looking For.
Must Have
University degree in pharmacy, medicine, life sciences or related field, Experience in GVP of at least three years, Documented education in pharmacovigilance, Demonstrated ability to work independently, Demonstrated ability to work in project settings, Excellent knowledge of English, Excellent knowledge of German
Nice to Have
Business understanding, Customer focus, Timeliness, Accountability, Delivery of reliable results, Autonomy work
What You'll Do.
Maintain oversight of safety-related processes
Quality control ICSRs
Timely submission of ICSRs
Process periodic safety reports
Quality control periodic safety reports
Timely submission of periodic safety reports
Act as local PV contact point in Switzerland
Handle pharmacovigilance tasks for AZ product portfolio
Handle pharmacovigilance tasks for AZ Group of companies
Apply GVP rules on QMS
Participate in implementation of local risk minimization activities
Participate in direct healthcare professional communication
Review Market Research activities
Review Patient Support programs
Contribute to setting up Safety Agreements
Support organization of PV awareness training
Ensure local Business Continuity Process is in place
Test local Business Continuity Process annually
Participate in Audits
Participate in inspections
How You'll Work.
Team & Collaboration
Team work cross functionally; International environment
Communication Scope
Communication skills; Influencing skills
Process & Methodology
Project management
Full Job Description
**_Senior Specialist Patient Safety_** Location : Baar , Switzerland **Do you have expertise in, and passion for, Patient Safety? Would you like to apply your expertise in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!** 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. **Come and join our AZ team where you will play a pivotal role in this exciting period of development!** This role will provide a high quality, comprehensive, technical, and scientific pharmacovigilance service in the management and day-to-day processing of pharmacovigilance activities. In addition to this, it will also provide knowledge and expertise to internal and external customers on all aspects of Patient Safety relating to AstraZeneca Portugal activities and fully comply with Good Pharmacovigilance Practice (GVP) requirements and all other AZ policies and Standards. **Main Accountabilities:** The role broadly includes the following key components: * Maintain oversight of all safety-related processes, including processing, quality control, and timely submission of ICSRs and periodic safety reports (PBRERs, DSURs, RMPs) to local health authorities. * Deputy of the PSM, acting as local PV contact point in Switzerland * Responsible for handling pharmacovigilance tasks for the AZ product portfolio And AZ Group of companies (including Alexion) * in the country in alignment with applicable regulations and AstraZeneca Standard Operational Procedures and act as the deputy of responsible person for pharmacovigilance in Switzerland * Responsible for applying the GVP rules on the QMS for AZ Switzerland PS activities * Participate in the implementation of local risk minimization activities and direct healthcare professional communication. * Review Market Research a
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