Senior Safety Scientist AstraZeneca Gothenburg

Job description
At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Our purpose is ambitious and so is our approach. Creating a more agile and inclusive environment means building a culture where we celebrate innovative thinking.
Our Patient Safety team sits within the Chief Medical Office; an integrated, enterprise-wide organisation dedicated to defining the benefit/risk assessment of our medicines across the life-cycle, acquiring and maintaining health authority approvals around the world.

The Senior Pharmacovigilance (PV) Scientist role leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and other PV Scientists. He/she authors and leads PV input to safety documents and regulatory reports. Senior PV Scientist leads meetings and presents safety data and analyses.

Responsibilities


Leads and/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products.
Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
Leads the cross-functional Safety Strategy and Management Team (SSaMT) for large and/or complex projects.
Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
Leads and authors the Reference Safety Information (RSI) for multiple and/or complex development products and collaborates with GSP and Clinical representatives as needed
Authors/provides strategic input or oversight for multiple and/or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
Trains and mentors junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.


Qualifications
• A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience
• Fluent in written and verbal English
• Advanced knowledge of PV regulations
• Intermediate understanding of epidemiology, preferred

Application
2021-05-27, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.


For more information: Birgitta Nyström birgitta.nystrom@randstad.se or Linnéa Öster linnea.oster@randstad.se. 

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!