Associate Director Patient Safety Scientist
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Job Location:
Monthly Salary:
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
At AstraZeneca we turn ideas into life-changing medicines. Working here means being entrepreneurial thinking big and working together to make the impossible a reality. We do this with integrity even in the most difficult situations because we are committed to doing the right thing.
Patient Safety BioPharma at AstraZeneca is now looking for a Patient Safety Scientist to join our team.
The core purpose of AstraZeneca Patient Safety is to add value to AstraZeneca products provide clear science-based guidance for investigators and prescribers to safeguard patients as well as the success of our business. Patient Safety covers the entire clinical life cycle of a drug from first time into man to withdrawal of a product from the market
As a Patient Safety (PS) Scientist you work with Patient Safety Physicians and other PS Scientist(s) with review analysis and interpretation of safety data obtained from patients who have been administered the assigned medicinal products in clinical development programs and/or from marketed use. You provide authoring and input to safety documents and regulatory reports and lead internal and external meetings to present safety data and analyses. You evaluate the clinical implications of safety data from pre-clinical studies clinical studies literature and other information sources to establish the safety profile of drugs and manage the risk to patients.
Main Responsibilities
Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products including preparation of safety aspects of Global Risk Management Plans in partnership with the Global Safety Program Lead (GSPL) and others as appropriate.
Represents Patient Safety on cross-functional project teams for developmental compounds and/or marketed products.
Presents issues to Safety Information Review Committee (SIRC) and has the capacity to take the lead role in data evaluation and discussion of the results with the SIRC Chair GSPL and other key stakeholders.
Produces accurate and fit for purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
Collaborates with GSPL and Clinical representatives and authors the Reference Safety Information (RSI) for assigned development products; coordinates meetings and tracks timelines to ensure completion.
Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs PSURs DSURs) according to the agreed process and timelines.
Authors/provides strategic input to regulatory submissions for new products formulations or indications (NDA/BLA MAA) in partnership with the GSPL and other functional experts.
Contributes to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreement.
Trains junior members of the team in Patient Safety tools and systems
Essential Requirements
A life sciences/pharmacy/nursing degree
Demonstrated Patient Safety experience working at least 2 of the following areas:
Clinical drug development (Early and/or Late Phase: program level safety strategy including proactive risk identification & mitigation planning)
Post-Marketing Surveillance (including signal detection & evaluation)
Periodic Safety Reports (strategy preparation and authoring)
Risk Management Plans (strategy preparation and authoring)
Intermediate knowledge of pharmacovigilance regulations
Fluent in written and verbal English
Basic understanding of epidemiology
Location: Onsite in Mölndal/Gothenburg
Why AstraZeneca
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -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.
Embrace the opportunity for development whether its upskilling or reskilling. We are a high-performing learning organization with autonomy over how we learn. We deliver innovative development experiences that sustain and grow future leaders and talent. Because we want all our people to embrace the challenges and opportunities ahead. This is the place to build a fulfilling long-term career.
So whats next
Are you ready to take the next step in your career and become part of our amazing team We look forward to receiving your application.
Date Posted
10-mars-2026Closing Date
23-mars-2026Our 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
Key Skills
- Laboratory Experience
- ELISA
- Immunoassays
- Transfection
- Mammalian Cell Culture
- Suspension Experience
- Biochemistry
- Assays
- cGMP
- Cell Culture
- Molecular Biology
- Flow Cytometry
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
