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Executive Director Patient Safety Biopharma
hace 3 meses
AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.
If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Patient Safety at AstraZeneca is now looking for an
Executive Director Major Program Patient Safety BioPharma to join our team in **Gothenburg, Sweden.
What you'll do
The Executive Director position is a global role providing strategic PS input for TA and/or Disease Areas and quality and compliance oversight to a family of drug development and post-marketing programs across life-cycle of substances and products.
In this position you will manage a global team of Global Safety Physicians and Strategic Safety Management Team Leaders, in order to support major PS programs and key initiatives.
Your main accountabilities / responsibilities:
- Drive staff development in support of AZ products
- Ensure that own work and work of team is compliant with Good Clinical and Pharmacovigilance Practice, Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
- Use expertise and knowledge of global issues to recruit and develop strategic Physicians and Scientists objectives for inclusion into business objectives
- Provide TA Disease Area strategic PS input to a family of drug development and postmarketing programs across lifecycle of substances and products e.g to dTPPs, patient populations, scientific understanding of toxicityrelated mechanisms, ensure risk management commitments, risk mitigation and communication.
- Be accountable at Portfoliolevel for quality incl review of key deliverables (eg RMPsand PSRs), and adherence to PV regulations.
- Define strategies or leads AstraZeneca's response to complex technical issues for specific safety aspects in relation to current projects, new projects and various plans
- Represent content matter expertise at high level decisionmaking bodies such as LSPC, SARB, ESB and Development Review Committee on behalf of the relevant PSTAVP
- Be responsible for SIRC Chair role and Chairperson consultation for assigned products
- Chair Patient Safety peer review
- Work across a number of disease areas in the TA and oversee Safety Physicians, Scientists and SSaMTs working in a portfolio of AZ assets in the TA
- Represent AZ PS in external regulatory meetings
- Influence AZ TA strategies
- Influence the Patient Safety interface with all Clinical Development groups and Regulatory Affairs leads in the TA and with the Commercial organisation
- Review and approve regulatory communication and preparation of higher level documents (eg RMPs, PBRER, DSUR, submission documents)
- Closely follow medical developments within assigned areas and disseminates new information within Patient Safety to transform trends and emerging data into new plans
- Follow important developments and trends in scientific literature and develops contacts with opinion leaders
- Share best practice in PS TA
- Participate in the PSTA BioPharma leadership team
Essential for the role
- Medical/clinical/scientific qualification and postgraduate training, or equivalent standards
- Experience in providing strategic leadership to complex drug projects
- Relevant industry experience in Pharmacovigilance field
- Experience in managing a scientific team
- Demonstrated ability to influence key partners within and outside of company
- Demonstrated proficiency with both written and verbal communications
Desirable for the role
- PhD in scientific field
- Extensive general medical knowledge
- Able to work across TAs and Functions
- Research background including peer reviewed publications
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?Join us and be part of an outstanding place to work; an environment that energizes and empowers each of us to achiev
