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 cross-functional 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 fit-for-purpose 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 pre-clinical 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 medico-legal aspects of patient safety
• 9 to 11 years of Patient Safety experience
• Total of 12 to 14 years of experience
Communication:
• Well-developed 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 cross-functional 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 life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're 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 high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge 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 hardest-to-treat 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!
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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.