Patient Safety Scientist 1
Job Title: Patient Safety Scientist 1
Patient Safety Scientist 1works collaboratively with the Global Safety Physician (GSP) and Senior/Principal PV Scientist with the review of safety data and related documents for potential safety issues. He/she has the ability to provide authoring and PV input to safety documents and regulatory reports. PV Scientist also has the ability to lead meetings and present safety data and analyses
Perform all Surveillance activities including monthly signal-detection activities and SIRC activities for established products with minimal supervision.
Able to draft the periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines for established products with minimal supervision.
Able to draft production of high-quality and timely responses to safety queries with minimal supervision.
Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals in partnership with the GSP, for all products in area of responsibility.
Support a performance-driven culture
Raises appropriate concerns/issues to senior staff in a timely manner.
Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) leader for smaller or less complex projects
Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures
Compliance with relevant procedural documents
Ensure good communication and guidance to AZ products
Liaise effectively and maintain excellent relationship with external contacts
Support a performance-driven culture
Minimum Requirements –Education and Experience
Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety/clinical development
Comprehensive understanding of applicable Patient Safety regulatory obligations in EU
Awareness of Patient Safety policies, processes and procedures
Awareness of medico-legal aspects of patient safety
Up to 4 to 6 years Patient Safety experience (with clear evidence of delivery
Total of 7 to 9 years of experience
Skills and Capabilities
The role holder will have:
Ability to work effectively as a member of a cross-functional or global team
Ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas
Good communication skills with the ability to work across cultures
High ethical standards, including a commitment to AstraZeneca values and behaviours
Ability to appreciate diversity and work as equals with global and cross-functional teams
Internal and External Contacts/Customers
Patient Safety personnel at all levels
Regulatory Affairs and other AstraZeneca personnel
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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 authorisation and employment eligibility verification requirements.