Principal Pharmacovigilance Scientist
AstraZeneca AB / Biomedicinjobb / Göteborg
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hela Sverige At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue extraordinary medicines in new ways, combining our people's outstanding skills with those of people from all over the globe.
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 looking for a Principal Pharmacovigilance (PV) Scientist to work in the Respiratory Therapeutic Area, to join our team in Gothenburg, Sweden.
Main Duties and Responsibilities
As a Principal PV Scientist, you will provide expertise to multiple and/or single but complex products in different stages of development as needed. You will lead the review, analysis and interpretation of safety data obtained from patients who have been administered the assigned medicinal products in collaboration with the Global Safety Physician (GSP) and other PV Scientist(s). You will apply your strong leadership, pharmacovigilance and scientific knowledge skills in guiding the authoring of as well as providing strategic input to safety-related documents. Main responsibilities include:
* Leading the strategy for proactive pharmacovigilance and risk management planning of complex or multiple products, including preparation of the safety aspects of Global Risk Management Plans in partnership with the GSP and others as appropriate.
* Providing subject matter expertise in the therapeutic area and across multiple products.
* Having the ability to lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization.
* Performing duties as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products.
* As a Safety expert leading presentation of complex issues to Safety Information Review Committee (SIRC).
* Leading safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
* Leading safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
* Leading negotiations and providing expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.
* Taking accountability and leading resolution of complex safety issues and mediating cross-functional agreement.
* Having the ability to participate in due diligence activities.
* As a safety expert, providing training and mentorship to new GSPs and PV Scientists in processes and systems.
This role reports to the Pharmacovigilance Science Director, Patient Safety RIAIV.
Essential Requirements
* A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical Development experience, with proven relevant / related work experience
* Extensive (i.e. at least 10 years) experience in pharmacovigilance and drug development activities
* Advanced knowledge of PV regulations
* Advanced understanding of scientific methodology
* Advanced understanding of epidemiology data
* Clear evidence of leading teams in cross-functional collaborations and delivery
* Proven communication skills, interest in and knowledge of cultural diversity
* Able to influence whilst maintaining independent and objective views
* Proven ability to deal with complexity under time pressure
* Proven planning and organizational skills
* Proven project management skills
* Proven people management skills
* Fluent in written and spoken English
* Maintains high ethical standards in compliance with Good Clinical Practice (GCP)
Desirable Requirements
* Early clinical development experience
* MAA/NDA/BLA submission experience
* Experience in the Respiratory therapy area
* MSc/PhD in scientific discipline
We would like to know more about you. If you are interested, apply now!
Welcome with your application no later than December 15, 2019. For more information about the position please contact Hiring Manager Mona Thorsén (+46 706 76 0005).
AstraZeneca is acting as an Employment Agency in relation to this vacancy.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2019-11-18ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-12-16
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-066087".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 4960697
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