الوصف الوظيفي
Job Title - Associate Director, Senior Patient Safety ScientistCareer Level -EIntroduction to roleAccountabilities Lead and/or conduct proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans (RMP) and/or Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate. Lead PS activities of cross-functional project teams for marketed products and/or developmental compounds. Provide safety expertise to Investigator Brochures and Protocols, Informed Consents, and Clinical Study Reports. Perform duties as a Safety Strategy and Management Team (SSaMT) Leader for larger or more complex projects. Present complex issues to the Safety Information Review Committee (SIRC) and take the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP, and other key stakeholders. Collaborate with GSP and Clinical representatives to author the Reference Safety Information (RSI) for multiple or complex marketed products and/or development products. Author/provide strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines. Participate in negotiations and provide expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements. Train and mentor junior members of the team in approved PV processes, analytic methodologies, etc. Author/provide strategic leadership 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 11 to 13 years Patient Safety experience (Pharmacovigilance) Total of 14 to 16 years of experienceDesirable Skills/Experience Well-developed interpersonal skills Cultural sensitivity Ability to network with other functions globallyWhen 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 are committed to reimagining how we work by finding solutions to operate more efficiently on a global scale. Our entrepreneurial approach challenges the status quo and takes calculated risks to transform processes through simplification, automation, and data analytics. We are a trusted partner to the business, driving new ways of working and innovative solutions while ensuring that automation and data are at the heart of everything we do. Join us on our journey of growth and evolution as we strive to make a difference for patients worldwide.50056681 E CDSU TranscriptOne of the things that I really enjoy about working for AstraZeneca is that I learn new things all the time. And there's a lot of space and a lot of support for developing my skills and for excelling at my role. Even though I haven't been with the company for very long, I've already witnessed several of my colleagues take part in both local and global programmes where they develop their skills, but also bring a lot of useful knowledge and information back to our local teams. Also, a lot of innovative ideas and projects are shared across the teams, and this is very inspiring. My ideas that I have had have always been supported by my local team and always been discussed to find new ways of bringing our work to the next level. This kind of openness and support for developing both your own skills, but also developing the company, is something that I value very highly in my work, and therefore, I really enjoy working for AstraZeneca.
