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Demanda en Suecia (Västra Götalands län) de Biólogos, botánicos, zoólogos

Senior Pharmacovigilance Scientist

Clasificación del trabajo: Profesionales científicos e intelectuales : Profesionales de las ciencias y de la ingeniería : Profesionales en ciencias biológicas : Biólogos, botánicos, zoólogos y afines.
Arbete som kräver teoretisk specialistkompetens : Arbete som kräver teoretisk specialistkompetens inom naturvetenskap och teknik : Specialister inom biologi, jord- och skogsbruk m.m : Biologer, botanister, zoologer m.fl.

Descripción de la oferta de trabajo:

Senior Pharmacovigilance Scientist within Respiratory, Inflammation, Autoimmunity (RIA) and Cardiovascular, Metabolic Disease (CVMD)

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?

We are looking for two Senior Pharmacovigilance Scientists in Patient Safety RIA and CVMD therapeutic areas.

As Senior Pharmacovigilance (PV) Scientist you lead reviews and interpretations of safety data obtained from patients who have been administered the assigned medicinal product in clinical development programs and/or from marketed use. You also present safety data and analyses in different fora and you lead PV input to safety documents and regulatory reports.

The Role

As a member/leader of the safety surveillance team for the assigned product/products, you will be working with a team of patient safety experts (physicians, other scientists) and collaborating with colleagues from across AstraZeneca and externally. Areas of responsibility include:

* 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 Patient Safety 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.

* Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) Leader for larger or more 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 the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products.

* Authors/provides strategic input or oversight for multiple 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.

* Participates in negotiations and provides expertise to the Patient Safety component of contracts/agreements with third parties to ensure quality and integrity of agreements.

* Trains and mentors junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.

Minimum requirements in experience and competence:

* A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical Development experience

* At least 5 years' experience in pharmacovigilance and drug development activities from a Patient Safety perspective

* Good knowledge of PV regulations

* Advanced understanding of scientific methodology

* Good understanding of epidemiology data

* Demonstrable leadership skills

* Able to work with autonomy

* Able to work effectively as part of or as the lead of a cross-functional or global team

* 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

* Proven commu

Servicio de empleo de origen: Arbetsförmedlingen, Servicios Públicos de Empleo, Suecia.

País del trabajo: Suecia.

Región: Västra Götalands län.

Ver 947 ofertas de trabajo en "Västra Götalands län" (Suecia).

Fecha de inicio: 17/10/2017.

Nº de vacantes: 1.

Experiencia: No se precisa.

Nivel educativo requerido: Sin especificar.

Carnet de conducir: No.

Horas semanales: Heltid Permanent.

Tipo de contrato: Jornada completa.

Duración del contrato: Indefinido.

Cómo solicitar: Otros (véase la descripción).

Cómo solicitar el puesto:
AstraZeneca titel : telefon 1: () telefon 2: () mobil: e-post: ulrica.marklund1Reemplazar por una

Link to the vacancy on the Swedish job board

Empresa: AstraZeneca.

Dirección: 43183 43183 1480.

Contacto: AstraZeneca titel : telefon 1: () telefon 2: () mobil: e-post: ulrica.marklund1Reemplazar por una

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