Surveillance Scientist @ AstraZeneca Degree level in biosciences or an
equivalent healthcare or Pharmaceutical industry
Description
Associate Patient Safety Scientist should be able to support the Global
Safety Physician (GSP) and (Senior/Principal) PV Scientist with the review of
safety data and related documents to identify and escalate potential safety
issues. He/she has the ability to
provide the first draft of safety documents and regulatory reports, and will
participate in meetings, as necessary.
Accountabilities/Responsibilities
Perform all Surveillance activities including monthly signal-detection
activities and SIRC activities for established products with supervision.
Able to draft the periodic regulatory documents (PBRERs, PSURs, DSURs)
according to the agreed process and timelines for established products with
supervision.
Support or draft production of
high-quality and timely responses to safety queries with 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.
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
Awareness of Patient Safety policies, processes and procedures
Awareness of medico-legal aspects of patient safety
Up to 2 to 4 years Patient Safety experience (with clear evidence of
delivery
Total of 6 to 8 years of experience
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