Associate Director Senior Patient Safety Scientist Full-time

Associate Director, Senior Patient Safety Scientist

Location: Barcelona – Spain (3 days working from the office and 2 days working from home)

At AstraZeneca, we work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutions to challenges. We do this with integrity, even in the most difficult situations, because we are committed to doing the right thing.

This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programs spanning the entire life cycle of drug development and peri-/post-submission. Our Scientists and Physicians play a strategic role in the development of our medicines and in shaping the safety science of each program. AstraZeneca's oncology pipeline, which includes novel combinations and modalities, provides an intellectual challenge to the safety teams and requires a broad scientific perspective, strong strategic thinking, and effective cross-functional leadership. As our portfolio evolves, so do the opportunities for our teams to grow in impact and expertise.

Role Responsibilities

In this exciting and challenging role, you will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians, playing a key role in defining, shaping, and delivering the safety strategy for your assigned drug project(s). You will apply your scientific knowledge and pharmacovigilance expertise to support proactive safety planning across the product life cycle, including risk identification, evaluation, mitigation, and communication, with the ultimate goal of protecting patients and supporting robust benefit-risk decision-making.

Your ability to work collaboratively and influence across the matrix will facilitate interactions with colleagues from across AstraZeneca, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams. You will be expected not only to contribute deep scientific and safety expertise, but also to provide leadership within cross-functional discussions, represent Patient Safety in relevant forums and governance interactions, and help drive alignment on key safety topics and strategic decisions.

As an Associate Director, Senior Patient Safety Scientist, you will lead or contribute to the aggregation, review, analysis, and interpretation of safety-related data in order to generate meaningful insights that inform decisions by prescribers, patients, payers, and internal stakeholders. You will use scientific judgment to assess emerging safety information, contribute to the development and execution of program-level safety strategy, and support the communication of safety risks in a clear, balanced, and patient-focused way.

You will deliver all aspects of safety documentation, including authoring and/or providing strategic safety input to regulatory documents such as regulatory reports, health authority responses, marketing authorization applications, periodic safety reports, and risk management plans. In addition, you may contribute to the preparation of governance materials and represent safety considerations in cross-functional discussions that support development and regulatory milestones.

As a senior member of the team, you will also be expected to contribute to the broader effectiveness of the function by coaching and mentoring less experienced colleagues, sharing knowledge and best practices, and helping to build scientific and strategic capability within the team.

Patient Safety sits within the Chief Medical Office, where we have a crucial role to play. This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our medicines portfolio means we have a drug-development pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines. Faced with complex disease challenges, we focus on exceptional performance to drive the best and most progressive drug development programs ever.

Minimum Education, Experience and Skill Requirements

Education: MD, MSc, PhD, or PharmD in a scientific field.

Minimum of 6+ years of relevant experience

Patient Safety and/or Clinical/Drug Development proven experience working in safety and/or scientific activities in at least 3 of the following areas:

• Clinical drug development (Early and/or Late Phase; develop and deliver program-level safety strategy, including proactive risk identification and mitigation planning)
• Post-Marketing Surveillance (including signal detection and evaluation)
• MAA/BLA submissions (preparation and authoring of the safety-related aspects of the Common Technical Document)
• Periodic Safety Reports (strategy, preparation, and authoring)
• Risk Management Plans (strategy, preparation, and authoring)
• Governance board interactions and communication across a range of activities

Good knowledge of PV regulations

Demonstrated ability to handle more than one activity simultaneously, prioritize effectively, and identify key issues

Ability to work effectively in an advanced matrix structure

Demonstrated ability to influence cross-functional teams and contribute to strategic decision-making

Experience coaching, mentoring, or supporting the development of colleagues is desirable for this level

Proficient in written and verbal English

Preferred Education, Experience and Skills

• Strong knowledge of hematology is highly preferred
• Understanding of epidemiology

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.