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Associate Director, Patient Safety Scientist
hace 3 meses
Location:
Onsite 3 days/week in Barcelona
At AstraZeneca we turn ideas into life-changing medicines. Working here means being ambitious, 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 PV 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 Physician (GSP) and others as appropriate.
- Represents Patient Safety on crossfunctional 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, GSP 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 GSP 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 GSP 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
Minimum Education, Experience and Skill Requirements
- A life sciences/pharmacy/nursing degree and demonstrated Patient Safety and/or Clinical/ Drug Development experience.
- Intermediate knowledge of pharmacovigilance regulations
- Fluent in written and verbal English
- Basic understanding of epidemiology
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