Job Description

Job Title: Associate Director, Patient Safety ScientistGlobal Career Level: EIntroduction 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. Thats why we work, on average, a minimum of three days per week from the office. But that doesn't 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.Why AstraZeneca?
At AstraZeneca, we follow the science to explore and innovate. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. We are driven by our shared belief in what science can do, a belief in its potential to redefine what's possible.Are you ready to push the boundaries of science to deliver life-changing medicines? Are you passionate about science and want to be part of a team that makes a bigger impact on patients' lives? Then there's no better place to be. Join us in our Biopharmaceuticals R&D team and be part of our journey!Apply now to make a difference!Date Posted 22-Nov-2024Closing Date 06-Dec-2024AstraZeneca 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.

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