Director, Principal Patient Safety Scientist - Oncology
Director, Principal Patient Safety Scientist - Oncology
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Job Description
Do you have expertise in and passion for Pharmacovigilance Would you like to apply your expertise to lead on complex PV projects in a company that follows the science and turns ideas into life changing medicines Then AstraZeneca might be the one for you!
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 worlds most serious diseases. But were more than one of the worlds leading pharmaceutical companies.
We are a science-based leading and decisive Oncology enterprise united in our vision to eliminate cancer as a cause of death. The pioneers we make bold moves that transform the way cancer is treated and truly improve patient outcomes. With one of the broadest and deepest Oncology pipelines in the industry there are many opportunities to work with new and novel drugs and help discover whats next.
What youll do
TheDirector Principal Patient Safety Scientist within Oncology Patient Safety is the highest level individual contributor scientist in our team structure before a team member elects to stay in technical project facing tract or moving into leadership tract leading and managing individuals within our organization. We are looking for someone who can demonstrate leadership within our environment and lead on complex PV projects through safety science expertise. You will lead PV strategy for complex products in different stages of development through input and delivery of safety documents and regulatory reports.
Your duties and responsibilities are likely to include:
Provide subject matter expertise in the therapeutic area and across multiple products
Lead the strategy for proactive PV and risk management planning of complex or multiple products including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with others as required.
Lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organisation.
Perform strategic safety leadership duties for complex and/or multiple products.
Lead presentation of intricate issues to Safety Information Review Committee.
Lead safety strategy for multiple or complex periodic regulatory documents (PBRERs PSURs DSURs) according to the agreed process and timelines.
Lead safety strategy for regulatory submissions of new products formulations or indications (NDA/BLA MAA) with other functional specialists.
Handle negotiations and provide expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.
Take accountability and lead resolution of safety issues and mediate cross-functional agreement.
Participate in due diligence activities.
Provide training and mentorship to new PV physicians and PV Scientists in approved processes and systems
Essential for the role
A degree in life sciences (or similar field) and advanced Patient Safety and/or Clinical/Drug Development experience
Excellent written and verbal English
Advanced knowledge of PV regulations
Clinical Development (Early and/or Late Phase)
Post-Marketing surveillance
MAA/BLA Submissions
Periodic Reports
Risk Management Plans (from scratch)
Governance Board Interactions
Desirable for the role
PharmD/MSc/PhD in scientific field
Advanced 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. 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.
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 co-creating a digital ecosystem with patients at its core.
Competitive salary and benefits package on offer.
The successful candidate will have access to a flexible employee benefits fund including holiday purchase and flexible time off pension contributions Share Save Plans A performance recognition scheme and a competitive generous remuneration package.
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
09-Jun-2025Closing Date
21-Jun-2025Our 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
