Patient Safety Specialist (m/w/d)
Zur befristeten Anstellung für 12 Monate in Holzkirchen bei einem Pharmaunternehmen.
Ihre Aufgaben als Patient Safety Specialist (m/w/d)
- Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Sandoz products from non-interventional studies, Patient Oriented Programs, Spontaneous Reports. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
- Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
- Interact and exchange relevant safety information with local HA, Patient Safety associates, other functional groups and third party contractor, if applicable.
- Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
- Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
- Develop and update training materials for pharmacovigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third party contractor, if applicable.
- Manage and maintain efficient Patient Safety filing and archive system.
Ihr Profil
- Education
- health care sciences professional (e.g. Medical Doctor, Nurse, Pharmacist) or
- natural scientist with experience in the area of pharmacovigilance and/or regulatory area and/or clinical development.
- Languages
- fluent in both written and spoken English; fluent in both written and spoken German language
- Experience/Professional requirement
- knowledge of national and international regulations for pharmacovigilance
- knowledge of pharmacological and medical terminology
- excellent communications, interpersonal and negotiation skills
- quality and focus oriented
- computer skills
- Abilitytowork in a diverse teamand in an areaof high workloadandwithcriticaltimelines
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Sie haben Interesse an der befristeten Stelle als Patient Safety Specialist (m/w/d)? Zögern Sie nicht und schicken Sie uns Ihre vollständige Bewerbung mit Lebenslauf, Referenzen und Zeugnissen sowie Ihren Gehaltsvorstellungen und Ihrem frühestmöglichen Eintrittsdatum direkt über den Bewerben-Link oder an Rebecca Brian, r.brian[at]realstaffing.com.Falls Sie mehr über die Stelle erfahren möchten, kontaktieren Sie uns gerne unter +49 (0) 69 264 89 8060.
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