Associate Director Risk Management (process)
AstraZeneca AB / Biomedicinjobb / Göteborg
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hela Sverige Do you have knowledge in Risk Management (RM) and Global Patient Safety ? Do you have a "can do" attitude and an innovative approach and want to contribute to ensure good relationships across Patient Safety and related functions within AstraZeneca? Then this unique role with a broad spectrum of responsibilities might be the one for you!
We are now recruiting an Associate Director Risk Management (process) to join our Safety Epidemiology and Risk Management team.
The core purpose of AstraZeneca Patient Safety is to add value to AstraZeneca products, provide clear science-based guidance for investigators and prescribers to safeguard patients as well as the success of our business. Patient Safety covers the entire clinical life cycle of a drug from first time into man to withdrawal of a product from the market. The Patient Safety Risk Management Group provide strategic advice when defining and implementing the risk management strategy. The process team within the PS Risk Management Group is responsible for robust and compliant processes to operationalize Risk Management strategy and implementation. We are a team of individuals who work across all the products and many different countries.
What you'll do
As an Associate Director Risk Management, you will take responsibility for the assigned maintenance, implementation and continuous improvement of Development and Post Market Risk Management (RM) and Benefit Risk (BR) Assessment processes and associated systems including:
* Ensuring compliance with applicable regulations and AstraZeneca Global and Local Policies.
* Collaboration with colleagues in Global Patient Safety (GPS) and Process and Partnership (P&P) Leads in PS CoE to share best practice and ensure consistency
* Collaboration with functions in R&D Oncology, R&D BioPharmaceuticals, AZ Marketing Companies and AZ Legal in order to support for process related activities.
* Innovative process solutions in order to develop state-of-the-art systems and technology
In the role as Associate Director Risk Management, you contribute to the strategic planning, lifecycle management and oversight of the RM & BR assessment component of the Pharmacovigilance Quality System, enabling business continuity and compliance and provide process training to relevant stakeholders and partners. You will be the primary contact for Risk Management Plan system (RMP Tracking tool) customer/user support and work with continuous improvement of related user guides in association with Business Tool owner and/or system owner, and you will manage records within the RMPsystem.
* Engage with stakeholders (internally and external) to find opportunities for continuous improvement, creative and innovative ideas to drive performance of processes, technology and services within RM and BR Assessment
* Identify opportunities and drive the development and/or enhancement of standards or techniques in order to improve the quality and efficiency of deliverables for the RM group and contribute to the development of the long term vision and mission of the RM group
* Identify any risk and issues within the RM and BR assessment processes and propose solutions to mitigate them.
* Working with the RM Group, monitors and reports on benchmarking activities and performance metrics relating to RM and BR assessment.
* Participate and /or support activities for GVP, GCP, GRP and GMP audits/inspections as required
* Working with the RM process owners, the compliance and inspection readiness experts, develop, establish, monitor, report and assess agreed global KPIs related to RM data reporting. Deliver Corrective and Preventative Actions to time and quality and identify data or trends identified through the Quality and Management Process
* Maintains an awareness of current, new and changing legislation relating to RM and BR assessment and understands and implements the impact of changes, as required
Essential
* A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
* Experience in patient safety/pharmacovigilance and RM, including applicable industry experience
* Knowledge and understanding of relevant global regulatory requirements and an ability to balance this with industry standards to achieve business goals
* Experience in design, development, implementation, maintenance, continuous improvement and ongoing customer support for business processes
* General knowledge of project management skills,
* Experience in audits/inspection activities as related to PV
* Able to work with a degree of autonomy
* Ability to rapidly comprehend the AZ organisation and agility in maneuvering across the organisation
* Good strategic thinking capability
* Excellent communication and time management skills
Desirable
* Knowledge of new and developing regulatory and pharmacovigilance expectations
* Experience of authoring standards documents (Standard Operating Procedures)
* Experience working with external vendors
* Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry
* Experience of development and provision of training through virtual meetings and other mediaAble to represent AstraZeneca externally where required
Why AstraZeneca?
Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with a sense of urgency. We are ambitious, take informed risks and learn from both success and failure. We are curious, creative and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Are you ready to move forward in your career?
So, what's next!
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. Please apply no later than, 30 July, 2023.
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2023-07-27
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-170804".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Kontakt AstraZeneca
nadja.bergman@astrazeneca.com Jobbnummer 7927620
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