Associate Director,â¯Patient Safety Scientist
Associate Director,â¯Patient Safety Scientist
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Job Description
Job Title: Associate Director Patient Safety Scientist
Global Career Level: E
Introduction to role:
The Associate Director Patient Safety Scientist role works collaboratively with the Global Safety Physician (GSP) and Senior Patient Safety Scientist to review safety data and related documents for potential safety issues. This role involves authoring and providing pharmacovigilance input to safety documents and regulatory reports. The Associate Director also leads meetings and presents safety data and analyses.
Accountabilities:
Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products including preparation of safety aspects of Global Risk Management Plans in partnership with the GSP and others as appropriate.
Represents Patient Safety on crossfunctional project teams for marketed products and/or developmental compounds.
Presents safety information at external meetings.
Performs duties as a Safety Strategy and Management Team (SSaMT) leader.
Presents issues to the Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair GSP and other key stakeholders.
Produces accurate and fitforpurpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
Collaborates with GSP and Clinical representatives to author the Reference Safety Information (RSI) for assigned marketed products and/or development products; coordinates meetings and tracks timelines to ensure completion.
Proactively evaluates the clinical implications of safety data from preclinical studies clinical studies literature and other information sources to establish the safety profile of drugs and manage the risk to patients.
Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs PSURs DSURs) according to the agreed process and timelines.
Contributes to the Patient Safety component of contracts/agreements with third parties to ensure quality and integrity of agreement.
Trains junior members of the team in Patient Safety tools and systems.
Authors/provides strategic input to regulatory submissions for new products formulations or indications (NDA/BLA MAA) in partnership with the GSP and other functional experts.
Essential Skills/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 medicolegal aspects of patient safety
9 to 11 years of Patient Safety experience
Total of 12 to 14 years of experience
Communication:
Welldeveloped interpersonal skills
Cultural sensitivity
Ability to network with other functions globally
Impact on Business Results:
Quality and timeliness of work through surveillance and case handling activity
Provision of timely information meeting deadlines for compliance with regulatory reporting requirements for periodic reports safety due diligence of products and contributing to correct labeling through safety surveillance activities
Maintenance of efficient and effective processes with a focus on productivity
Internal and External Contacts/Customers:
Patient Safety personnel at all levels
Regulatory Affairs and other AstraZeneca personnel
Leadership Skills:
Passion for Customers: Engages in collaboration with customers by directly interacting with them to ensure delivery of a complete solution.
Thinks Strategically: Applies a broad perspective by using knowledge and experience to challenge and adapt current approaches/ways of doing things.
Acts Decisively: Makes effective decisions under pressure in the absence of complete information and seeks support when needed.
Drives Performance: Holds immediate team accountable to quality standards by clarifying the objectives and timelines for deliverables.
Works Collaboratively: Integrates diverse views by seeking input and incorporating crossfunctional views into decisions/proposals.
Develops People and Organisation: Provides support and feedback to junior staff while continuing to develop him/herself.
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca we follow the science and pioneer new frontiers. Join our team dedicated to Oncology with an ambition to eliminate cancer as a cause of death. With multiple indications and highquality molecules at all stages of our innovative pipeline we keep pushing forward. Fusing cuttingedge science with the latest technology to achieve breakthroughs. Backed by investment we aim to deliver 6 new molecular entities by 2025. Our courage curiosity and collaboration drive us to make bold decisions driven by patient outcomes. Empowered to lead at every level we are free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team. Pioneers of collaborative research we have built an unrivalled scientific community both internally and externally. Working seamlessly and inclusively together we expedite research in some of the hardesttotreat cancers. Join us to build a rewarding and meaningful career as part of a team committed to improving the lives of millions with cancer.
Ready to make a difference Apply now!
Date Posted
13May2025Closing Date
13Jun2025AstraZeneca 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 industryleading 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 nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.
Required Experience:
Director
Employment Type
Full-Time
