Manager, Patient Safety Scientist

Job Title: Manager, Patient Safety Scientist

Career Level: D

Introduction to role

Are you passionate about patient safety and eager to make a difference in the world of pharmaceuticals? As a Manager, Patient Safety Scientist, you will work collaboratively with the Global Safety Physician (GSP) and Senior Safety Scientist/SSaMTL to provide pharmacovigilance input to safety documents and regulatory reports. You will also have the opportunity to present safety data and analyses in meetings, contributing to our mission of delivering life-changing medicines.

Accountabilities

• Perform all surveillance activities including periodic report production, leading monthly signal-detection activities, and SIRC activities for established products.
• Author/provide strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Produce high-quality and timely responses to safety queries.
• Identify and use appropriate sources of information and database searches to retrieve relevant data for evaluation of signals for all products in your area of responsibility.
• Foster a culture devoted to growth and achievement.
• Raise appropriate concerns/issues to senior staff in a timely manner.
• Lead the Safety Strategy and Management Team (SSaMT) for established products.
• Perform end-to-end pharmacovigilance activities independently on established products.
• Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes, and procedures.
• Provide strategic and scientific input into regulatory authority submissions, queries, and discussions.
• Support responses to queries/impositions by regulators, with a high level of attention to implications in other countries.
• Ensure good communication and guidance to AZ products.

Essential Skills/Experience

• Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety (pharmacovigilance)/clinical development.
• Comprehensive understanding of applicable Patient Safety regulatory obligations in the EU.
• Awareness of Patient Safety policies, processes, and procedures.
• Awareness of medico-legal aspects of patient safety.
• 4 to 7 years of Patient Safety experience (with clear evidence of delivery).
• Total of 7 to 10 years of experience.

Desirable Skills/Experience

• Ability to work effectively as a member of a cross-functional or distributed team.
• Ability to work with autonomy.
• Ability to acquire and assimilate knowledge in different fields, disease, and therapeutic areas.
• Good communication skills with the ability to work across cultures.
• High ethical standards, including a commitment to AstraZeneca values and behaviors.
• Ability to appreciate diversity and work as equals with global and cross-functional teams.

Communication:

• 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 making a difference by fusing data and technology with the latest scientific innovations. Our passion for science drives us to explore new frontiers in treating, preventing, modifying, and even curing some of the world's most complex diseases. We celebrate our successes and learn from our failures as we push the boundaries of science to deliver life-changing medicines. Our inclusive environment encourages collaboration across diverse teams, leveraging global knowledge to create the greatest impact on disease.

Ready to make a meaningful impact? Apply now and join us on this exciting journey!

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 authorization and employment eligibility verification requirements.