Pharmacovigilance Scientist
AstraZeneca / Apotekarjobb / Göteborg
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hela Sverige 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.
Are you looking for a position where you truly can make an impact and have the opportunity to collaborate across global boundaries?
Patient Safety covers the entire clinical life cycle of a drug from planning before first time in man to withdrawal of a product from the market. We are now looking for a Pharmacovigilance (PV) Scientist to join the team in Patient Safety (PS), Respiratory, Inflammation & Autoimmunity (RIA) therapeutic area.
Main Duties and Responsibilities
As a Pharmacovigilance Scientist, you work with the Global Safety Physician (GSP) 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 PV input to safety documents and regulatory reports and lead internal and external meetings to present safety data and analyses.
Some more specific responsibilities in your role are:
* Lead and/or conduct proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans, in partnership with the GSP and others as appropriate.
* Represent PS on cross-functional project teams for developmental compounds and/or marketed products.
* Performs duties as a Safety Strategy and Management Team (SSaMT) leader for smaller or less complex projects.
* 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 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.
* Proactively evaluates 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.
* 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.
Minimum requirements in experience and competence:
* A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical Development experience
* Intermediate knowledge of PV regulations
* Proven analytical skills
* Understanding of scientific methodology
* Basic understanding of epidemiology data
* Demonstrable leadership skills
* A flexible, team orientated attitude, willing to contribute own skills to deliver AstraZeneca priority projects
* Proven ability to deal with complexity under time pressure
* Able to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas
* Able to influence whilst maintaining independent and objective views
* Good attention to detail
* Fluent in written and spoken English
* Maintains high ethical standards in compliance with Good Clinical Practice (GCP)
Preferred experience/requirements:
* Previous working experience from pharmacovigilance activities in a Pharmaceutical company, Academic research or Health Authority environment
* MSc/PhD in scientific discipline
More information
For more information about the position please contact Ing-Britt Joelson at +46 709 14 90 59 or Mona Thorsén +46 706 76 00 05.
Welcome with your application no later than 19 June, 2018.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-06-05ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-06-19
Ange följande referens när du ansöker: R-028793
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
daniela.borquez@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4188930
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