Director Principal Patient Safety Scientist
Director Principal Patient Safety Scientist
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$ 177270 - 265905
1 Vacancy
Job Description
At AstraZeneca we deliver lifechanging medicines to millions of people globally. Our purpose is ambitious and so is our approach. Crafting a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking. Our strategy and ability to transform our medicines portfolio means we have a drugdevelopment pipeline that presents incredible opportunities to push the boundaries of science. Faced with complex disease challenges we focus on outstanding performance to drive the worlds best and most progressive drug development programs.
Our team is looking for a Director Principal Patient Safety (PS) Scientist to lead the strategy for proactive PV and risk management planning of multiple complex products within 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 to shape the culture of the safety team and the wider PSTA function. You will facilitate collaboration with colleagues from across AstraZeneca and externally including counterparts within Clinical Project Teams Global Regulatory Affairs and Global Commercial teams.
This opportunity will further develop your pharmacovigilance (PV) expertise in safety program spanning the entire life cycle of drug development and peri/postsubmission. Our Scientists and Physicians play a strategic role in developing our medicines and the safety science of the program. AstraZenecas 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.
Accountabilities:
Provide subject matter expertise and leadership in the therapeutic area and across products.
Lead the safety surveillance strategy and the presentation of sophisticated safety issues to crossfunctional teams and governance committees as well as periodic safety reports and health authority responses.
Partner with the GSP and other functional specialists to lead the safety strategy for regulatory submissions of new products formulations or indications (NDA/BLA MAA).
Participate in due diligence activities negotiating the PV components of contracts/ agreements with third parties to ensure quality and integrity of these documents.
Provide training and mentorship to other PV Scientists and junior physicians.
Essential Skills/Experience:
BS in sciences/pharmacy/nursing or related field
7 years of relevant experience
Advanced Patient Safety and/or Clinical/Drug Development experience of leading safety &/or scientific activities across at least 4 of the following areas:
Clinical drug development (Early and/or Late Phase: develop program level safety strategy including proactive risk identification & mitigation planning)
PostMarketing 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
Advanced knowledge of PV regulations
Demonstrated ability to handle more than one complex project simultaneously prioritizing well and recognizing key issues
Ability to work effectively in an advanced matrix structure
Proficient in written and verbal English
Desirable Skills/Experience:
MS or PhD in relevant scientific field preferred
5 additional years of proven experience
Strong network and reputation within the business and industry
Extensive knowledge of the latest technical and regulatory expectations
The annual base pay for this position ranges from $177270 to $265905. Hourly and salaried nonexempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location jobrelated knowledge skills and experience. In addition our positions offer a shortterm incentive bonus opportunity; eligibility to participate in our equitybased longterm incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an atwill position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
In Office Requirement:
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
So whats next:
Are you already envisioning yourself joining our team Good because we cant wait to hear from you!
Why AstraZeneca
At AstraZenecas Oncology R&D business area youll be part of a team playing a critical role in driving meaningful change in the way we predict prevent and treat patients conditions. Were 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. Were shaping the future improving and speeding up portfolio development improving the patient experience and outcomes at clinical trials. Join the team that is cocreating a digital ecosystem with patients at its core.
Date Posted
25Feb2025Closing Date
Our 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.Required Experience:
Director
Employment Type
Full-Time
