Associate Director, Senior Patient Safety Scientist

Job title:

Associate Director, Senior Patient Safety Scientist

Company

AstraZeneca

Job description

Role: Associate Director, Senior Patient Safety ScientistLocation: 3 days onsite in Luton UKAt 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 programmes, spanning the entire life cycle of drug development and peri-/post-submission. Our Scientists and Physicians play a strategic role in developing our medicines and the safety science of the programme. AstraZeneca’s oncology pipeline, which includes novel combinations and modalities, provides an 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, Senior Patient Safety Scientist to join our Patient Safety department, working 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. You 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.Essential RequirementsA Bachelor’s in sciences/pharmacy/nursing degree or related field with a minimum of 5 years of relevant experience or an advance degree with a minimum of 3 years of relevant experiencePatient 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 activitiesIn addition, you will need :Good knowledge of PV regulationsDemonstrated ability to handle more than one project simultaneously, prioritizing well and recognizing key issuesAbility to work effectively in an advanced matrix structurePreferred RequirementsMSc/PhD/PharmD in scientific fieldAdvanced understanding of epidemiologyIn Office Requirement: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.So, what’s next:Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you!Why AstraZeneca?At AstraZeneca’s Oncology R&D business area, you’ll be part of a team playing a critical role in driving meaningful change in the way we predict, prevent and treat patients’ conditions. We’re actively embracing and investing in technology, harnessing digital, data and analytics to reimagine the future of healthcare and deliver improved outcomes to patients beyond core medical. We’re shaping the future, improving and speeding up portfolio development, improving the patient experience and outcomes at clinical trials. Join the team that is co-creating a digital ecosystem with patients at its core.Date Posted 11-Dec-2024Closing Date 22-Dec-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

Expected salary

Location

Luton

Job date

Fri, 13 Dec 2024 04:45:32 GMT

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