Åsa Kjellström Email & Phone Number

Stockholm, Stockholm County, Sweden

Stockholm, Stockholm County, Sweden

Stockholm, Sverige

Uppsala, Sweden

Stockholm, Suède

Suède

Duties have consisted of surveillance and scientific activities, for marketed products as well as products under clinical development, including• productions of periodic safety reports • participation in signal detection• production and maintenance of Patient Risk Management Plans• providing scientific and technical expertise to project teams• leading production of high quality and timely responses to safety queries from regulatory authorities and internal sources• ensuring compliance with global and local procedural documents and regulatory requirements.• As group manager lead, manage and deploy a group of 12 medical and scientific staff. • Organisation of competence development in Patient Safety • Participation in due diligence activitiesThe work has to a large extent been performed in cross-functional and international collaboration.Duties have particularly called for ability to project manage across boundaries and lead colleagues to deliver, scientific and analytical skills, coordinating and collaborative skills as well as independence. In addition application of in-depth knowledge of specific product, therapeutic or technical areas has been required.Competences achieved include broad understanding of drug development with a preclinical safety perspective, knowledge of regulatory processes including NDA submission, presentation and teaching skills team work, cross-functional collaboration and leadership.

Södertälje

Implementation of a regional organisation, including assurance of increased awareness and understanding between the Swedish sites including competence development, as a member of Swedish Patient Safety Surveillance Leaderships Team. Lead, manage and deploy a group of 12 medical and scientific staff. Including resource allocation and individual personal development.

Södertälje

Duties included life cycle management of marketed products and regulatory submission.

Södertälje

Phd, Pharmacology

Education record