Associate Director, Senior Patient Safety Scientist
Job Title - Associate Director, Senior Patient Safety Scientist
Career Level -E
Introduction to role
Are you ready to lead the charge in ensuring patient safety and making a real difference? As an Associate Director, Senior Patient Safety Scientist, you will spearhead the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and Patient Safety Scientist. You will author and lead PV input to safety documents and regulatory reports, lead meetings, and present safety data and analyses. Join us in our mission to deliver life-changing medicines to patients worldwide
Accountabilities
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 experience
Desirable Skills/Experience
Well-developed interpersonal skills
Cultural sensitivity
Ability to network with other functions globally
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 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.
Ready to make an impact? Apply now!
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 authorisation and employment eligibility verification requirements.
