Patient Safety Senior Specialist

Patient Safety Senior Specialist

Location : Warsaw, Poland

Model: hybrid 3 days office + 2 days home office

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 Poland 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

Deputy of the local PV contact person for Pharmacovigilance in Poland

· Responsible for handling pharmacovigilance tasks for the AZ product portfolio in the country in alignment with applicable regulations and AstraZeneca Standard Operational Procedures

· Maintains oversight of all safety related processes, issues and brand activities within their country

· Responsible for applying the GVP rules on the QMS for AZ Poland PS activities

· Participate in the implementation of local risk minimization activities

· Review local Market Research activities and Patient Support programs.

· Ensures that all local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF)

· Contribute to the setting up of Safety Agreements with collaborative partners.

· Support organization of PV awareness training for internal employees and vendors.

· Ensures a local Business Continuity Process (BCP) for Patient Safety is in place and tested at least annually.

· Participate in Audits and inspections.

Essential for the role

· University degree in pharmacy, medicine, life sciences or related field.

· Experience in GVP of at least two years and documented education in the field of pharmacovigilance

· Demonstrated ability to work independently and in project settings to deliver objectives.

· Communication and influencing skills.

· Project management

· Team work cross functionally in an international environment.

· Excellent knowledge of English and local language (Polish) both spoken and written

Desirable for the role

· Business understanding and customer focus

· Timeliness, accountability, and delivery of reliable results

· Strong team player

· Autonomy work

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Global biopharmaceutical company focused on oncology, cardiovascular, renal, and respiratory therapies. Headquartered in Cambridge, UK.

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