AstraZeneca
Associate Director, Senior Patient Safety Scientist - Oncology R&D
AstraZeneca, Gaithersburg, Maryland, us, 20883
Job Title: Associate Director Senior Patient Safety Scientist
Location: Onsite 3 days in Gaithersburg MD
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 developing our medicines and the safety science of the program. 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
Associate Director, Senior 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. You will play a role supporting 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, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.
As an
Associate Director, Senior Patient Safety Scientist , you will be involved in aggregating, reviewing, analyzing 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 PV, oncology and scientific experience, knowledge and skills to deliver 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 authorization applications.
Minimum Education, Experience and Skill Requirements
A Bachelor’s in sciences/pharmacy/nursing degree or related field
3+ years of shown experience
Patient Safety and/or Clinical/Drug Development validated experience working in safety &/or scientific activities in at least 3 of the following areas:
Clinical drug development (Early and/or Late Phase: develop & deliver program level safety strategy, including proactive risk identification & mitigation planning)
Post-Marketing Surveillance (including signal detection & evaluation)
MAA/BLA submissions (preparation and authoring of the safety related aspects of the Common Technical Document)
Periodic Safety Reports (deliver strategy, preparation and authoring)
Risk Management Plans (deliver 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, prioritizing well and recognizing key issues
Ability to work effectively in an advanced matrix structure
Proficient in written and verbal English
Preferred Education, Experience and Skills
MSc/PhD/PharmD in scientific field
2+ years of relevant experience
Understanding of epidemiology
In 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.
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Location: Onsite 3 days in Gaithersburg MD
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 developing our medicines and the safety science of the program. 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
Associate Director, Senior 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. You will play a role supporting 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, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.
As an
Associate Director, Senior Patient Safety Scientist , you will be involved in aggregating, reviewing, analyzing 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 PV, oncology and scientific experience, knowledge and skills to deliver 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 authorization applications.
Minimum Education, Experience and Skill Requirements
A Bachelor’s in sciences/pharmacy/nursing degree or related field
3+ years of shown experience
Patient Safety and/or Clinical/Drug Development validated experience working in safety &/or scientific activities in at least 3 of the following areas:
Clinical drug development (Early and/or Late Phase: develop & deliver program level safety strategy, including proactive risk identification & mitigation planning)
Post-Marketing Surveillance (including signal detection & evaluation)
MAA/BLA submissions (preparation and authoring of the safety related aspects of the Common Technical Document)
Periodic Safety Reports (deliver strategy, preparation and authoring)
Risk Management Plans (deliver 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, prioritizing well and recognizing key issues
Ability to work effectively in an advanced matrix structure
Proficient in written and verbal English
Preferred Education, Experience and Skills
MSc/PhD/PharmD in scientific field
2+ years of relevant experience
Understanding of epidemiology
In 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.
#J-18808-Ljbffr