Manager, Patient Safety Scientist Oncology
hace 1 mes
**About AstraZeneca**
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.
**Come and join our AZ team where you will play a pivotal role in this exciting period of development**
**What you’ll do**
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.
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.
**Key Responsibilities**:
- Provide agreed patient safety input to pivotal study documents, e.g. Investigator Brochures, Protocols, Informed Consent Forms and Clinical Study Reports.
- Deliver periodic safety reports and take responsibility for running routine signal detection processes in partnership with the GSP.
- Be involved in aggregating, reviewing, analysing and interpreting safety-related data, generating information to support safety decision making by prescribers, patients and payers, with the ultimate goal of protecting patients.
- Work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians
- Supporting the safety strategy and requirements for your assigned drug project(s)
- Work collaboratively will facilitate cross-functional interactions with colleagues from across AstraZeneca, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.
**Required Experience, Skills, and Qualifications**
- A Bachelor’s in sciences/pharmacy/nursing degree or related field with a minimum of 2 years of relevant experience or an advance degree with a minimum of 1 year of relevant experience
- Patient Safety and/or Clinical/Drug Development experience working in safety &/or scientific activities in at least 1 of the following areas:
- Clinical drug development (Early and/or Late Phase: deliver programme level safety strategy, including proactive risk identification & mitigation planning)
- Post-Marketing Surveillance (including signal detection & evaluation)
- Periodic Safety Reports (preparation and authoring)
- Risk Management Plans (preparation and authoring)
- Knowledge of PV regulations
- Demonstrated ability to handle more than one activity simultaneously, prioritizing well and recognizing key issues
- Ability to work effectively in an advanced matrix structure
**Desired requirements**
- MSc/PhD/PharmD in scientific field
- Basic understanding of epidemiology
**Why AstraZeneca**
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
**So, what’s next**:
Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you
**Competitive salary and benefits package on offer.
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