This is a n opportunity to further develop your pharmacovigilance ( PV ) experience in safety programmes , spanning the entire life cycle of drug development and peri- /post- submission. O ur Scientists and Physicians play a strategic role in develop ing our medicines and the safety science of the prog r amme . AstraZeneca ’ s oncology pipeline, which includes n ovel combinations and modalities , provides a n intellectual challenge to the safety teams , requiring a broad portfolio and scientific management approach to projects. Our teams ’ experience develops as our portfolio does.

We are looking for an experienced Associate Director, Patient Safety (PS) Scientist to join our Patient Safety department, work ing in the Oncology Therapeutic Area. In this exciting and challenging role, you will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians , including coaching junior colleagues. You will play a leading role in delivering the safety strategy and requirements for your assigned drug project(s) . Your ability to work collaboratively will facilitate cross-functional interactions with colleagues from across AstraZeneca and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.

As an Associate Director, PS Scientist , you will provide leadership in aggregating , reviewing, analysing and interpreting safety-related data to generate information to support safety decision-making by prescribers, patients and payers, with the ultimate goal of protecting patients. Y ou will apply your strong PV , oncology and scientific experience , knowledge and skills to lead in all aspects of safety documentation , including authoring and / or providing strategic safety input to regulatory documents, e.g., regulatory reports , health authority responses and the safety content of marketing authorisation applications .

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 transformative drug development programmes ever.

Essential Requirements

• A Bachelor’s in sciences/pharmacy/nursing degree or related field with relevant experience or an advance degree with relevant experience

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

• Clinical drug development (Early and/or Late Phase : develop programme level safety strategy, including proactive risk identification & mitigation planning)

• Post-Marketing Surveillance (including signal detection & evaluation)

• MAA/BLA submissions (setting strategy; preparation and authoring of the safety related aspects of the Common Technical Document)

• Periodic Safety Reports (establish and lead strategy, preparation and authoring)

• Risk Management Plans ( establish and lead 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 project simultaneously, prioritizing well and recognizing key issues

• Ability to work effectively in an advanced matrix structure

• Fluent in written and verbal English

Preferred Requirements

• MSc/PhD/PharmD in scientific discipline

• Advanced understanding of epidemiology

Location: Barcelona

Salary: Competitive + Excellent Benefits