Location: Gaithersburg (3 days on site)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 world’s most ser... more details
Location: Gaithersburg (3 days on site)
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 world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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 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 what’s next.
What you'll do
The Director, 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 the Global Safety Physician and others as required.
Lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organisation.
Perform duties as Safety Strategy and Management Team Leader 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 the GSP and 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 GSPs 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
Salary: Competitive + Excellent Benefits
Requirements: 3 days on site a week
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 imagining yourself joining our team? Good, because we can’t wait to hear from you.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
Date Posted
09-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.
