Associate Director, Patient Safety Scientist
2 weeks ago
Associate Director, Patient Safety Scientist
Location: Onsite 3 days in Gaithersburg
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.
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.
We are looking for an experienced Associate Director, Patient Safety (PS) 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 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
Preferred Requirements
* MSc/PhD/PharmD in scientific field
* Advanced 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 ready to bring new ideas and fresh thinking to the table? Brilliant We have one seat available and we hope it's yours.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Date Posted
18-Apr-2024
Closing Date
06-May-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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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