Manager, Senior Patient Safety Scientist

Job Title: Manager, Senior Safety Scientist

Global Career Level: D2

Introduction to role:

Are you ready to lead safety surveillance that protects patients and shapes benefit–risk profiles across a global portfolio? The Manager, Senior Safety Scientist works collaboratively with Global Safety Physician (GSP) and SSaMTL or as a SSaMTL should lead scientific, technical or Patient Safety input for a product, group of products, systems or processes. He/she has the ability to provide authoring and PV input to safety documents and regulatory reports. Manager, Senior Safety Scientist also has the ability to lead meetings and present safety data and analyses

Accountabilities:

• Perform all Surveillance activities including periodic report production, leading monthly signal-detection activities and SIRC activities for established products.

• Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.

• Able to produce of high-quality and timely responses to safety queries

• Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals for all products in area of responsibility.

• Support a performance-driven culture

• Raises appropriate concerns/issues to senior staff in a timely manner.

• Safety Strategy and Management Team (SSaMT) leader for slightly more complex products

• Should be able to perform end to end Pharmacovigilance activity independently on the assigned products and should mentor others within their role.

• Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures

• Compliance with relevant procedural documents provide strategic & scientific input into regulatory authority submissions, queries, and discussions

• Support response to queries/impositions by regulators, with high level of attention to implications in other countries

• Ensure good communication and guidance to AZ products

• Liaise effectively and maintain excellent relationship with external contacts

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 in EU

• Awareness of policies, processes, and procedures related to patient safety

• Awareness of medico-legal aspects of patient safety

• 6 to 9 years Patient Safety experience (with clear evidence of delivery)

• Total of 10 to 12 years of experience

Desirable Skills/Experience:

• Capacity to function effectively as a member of a cross-functional or distributed team

• Ability to work with autonomy

• Ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas

• Good communication skills with 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

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.

Why AstraZeneca:

Here, curious minds come together to tackle complex disease with the full strength of deep biology, advanced analytics, and purposeful collaboration. You will work alongside colleagues and partners from academia and biotech, moving from discovery to late-stage development with the tools, data, and scientific freedom to make bold decisions. We bring diverse perspectives into the same room to spark new ideas, value kindness alongside ambition, and learn quickly from both successes and setbacks. Your contribution in patient safety will directly influence therapies reaching people who need them most and will help shape the future of healthcare.

Call to Action:

Step into a role where your safety leadership will protect patients and accelerate meaningful medicines—share your profile and show us the impact you’re ready to deliver!

Date Posted

Closing Date

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.