Drug Safety expert AstraZeneca Gothenburg

Job description
Are you experienced in Pharmacovigilance or Drug safety? We are now looking for a Pharmacovigilance expert / Drug Safety expert for an exciting consultant assignment at AstraZeneca with start in September.

Short role description
Support and drive discrete improvement projects relevant to the scope of the QPPV function.
To provide support for maintenance of Pharmacovigilance System Master File (PSMF), Summary of Pharmacovigilance System (SPS) and PRAC monitoring activities.
Provide project management support for dedicated project(s).


Responsibilities
Support and drive PV Excellence by inputting to ad hoc allocated tasks in relation to:
Developing and maintaining framework(s) for content quality measurement and oversight.
Assessing the effectiveness of initiatives with identification of subsequent further improvement actions as needed.
Developing standardised best practice templates, authoring instructions and guidance for production of Patient Safety outputs.
Promoting and ensuring Patient Safety outputs are produced in accordance with High Performance Authoring (HPA) principles.
Implementation of standards and skills with Patient Safety Therapeutic Area teams and individuals in close collaboration with Process Area Leads (PAL) and Process Owners (PO).
Ensuring the adoption of standards and skills by developing and providing process competence and capability build training to functional groups within Patient Safety.
Providing specialist knowledge and support to be recognized as experts and source of reference for safety teams and other stakeholders.
Contribution to the definition and assessment of measurable objectives and delivery targets.



Provide support for:
Maintenance of Pharmacovigilance System Master File (PSMF)
Summary of Pharmacovigilance System (SPS)
Monitor PRAC outputs per SOP


Provide project management support for dedicated projects

Upon request participate and/or support activities for GVP audits/inspections

Qualifications
Essential
Health professional degree (MD, PharmD, RPh, RN, or related degree) or master’s degree in life sciences, or related field
Extensive experience in patient safety/pharmacovigilance including applicable industry experience and seen as a subject matter expert
Extensive operational experience in production of core safety outputs
Good knowledge and comprehension of relevant pharmacovigilance legislation
Excellent medical writing skills
Excellent communication skills
Experience and ability to develop and implement new standards and best practices
Strong project management skills
Proven ability to lead teams and collaborate in a continuous improvement
Good strategic thinking capability


Desirable
Regulatory strategy knowledge and experience
Clinical development knowledge and experience
Lean Sigma experience

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2020-08-26, 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 Eleonor Ehrman +46733434109. 



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!