Safety Data Manager (m/f/d)

61440 Oberursel
06.12.2019

Daten dieser Anzeige

Job-ID: 011757357
Safety Data Manager (m/f/d)

Fresenius Kabi Deutschland GmbH

Germany

https://jobdb.softgarden.de/jobdb/public/jobposting/applyonline/click?jp=5555767

Case processing of ADRs from any source including data entry and MedDRA coding Compilation of case report narratives Quality control of data entry of ADRs in the corresponding database Reporting of Individual Case Safety Reports (ICSRs) to competent authorities (e.g. EMA) Design and execution of database searches in ARISg Provision of line listings from ARISg for compilation of Aggregate Safety Reports and Risk Management Plans Communication and exchange of safety information between Global Vigilance and the National Safety Officers via the internal safety information communication tool COSI Performance of database searches and complex analyses of side effect case reports with the use of MedDRA SMQs (standardized MedDRA Queries) Design and performance of specific, customised database searches e.g. in response to health authority requests Contribute to writing of handbooks and creating procedures and conventions for data handling in Global Vigilance Participation in the implementation of training new employees and employees of other departments with interfaces to Global Vigilance Constitute an interface between the Vigilance Competence Center Oberursel and Fresenius Kabi's National Safety Officers worldwide Working condition: Closing date for applications:

  / CAREER WITH A PURPOSE / Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients. Safety Data Manager (m/f/d) Your assignments Case processing of ADRs from any source including data entry and MedDRA coding Compilation of case report narratives Quality control of data entry of ADRs in the corresponding database Reporting of Individual Case Safety Reports (ICSRs) to competent authorities (e.g. EMA) Design and execution of database searches in ARISg Provision of line listings from ARISg for compilation of Aggregate Safety Reports and Risk Management Plans Communication and exchange of safety information between Global Vigilance and the National Safety Officers via the internal safety information communication tool COSI Performance of database searches and complex analyses of side effect case reports with the use of MedDRA SMQs (standardized MedDRA Queries) Design and performance of specific, customised database searches e.g. in response to health authority requests Contribute to writing of handbooks and creating procedures and conventions for data handling in Global Vigilance Participation in the implementation of training new employees and employees of other departments with interfaces to Global Vigilance Constitute an interface between the Vigilance Competence Center Oberursel and Fresenius Kabi's National Safety Officers worldwide Your profile Successfully complete education in a scientific healthcare profession, e.g. university degree in pharmacy (registration preferred) or veterinarian medicine At least 5 years working experience in pharmacovigilance and/or in a similar role in pharmaceutical industry Medical-scientific knowledge for clinical nutrition products, i.v. drugs, e.g. analgesics and anaesthetics and clinical research preferable Experience in Good Documentation Practice preferred, e.g. writing procedures, training materials, working with databases Experience in working with ARISg as pharmacovigilance database preferred Willingness to follow legal requirements for Pharmacovigilance, e.g. Good Pharmacovigilance Practices Excellent written and verbal communication skills in English and German Strong attention to detail along with the ability to meet deadlines PC skills to include solid working knowledge of Microsoft SharePoint applications and Microsoft Office software (Outlook, Word, Excel, PowerPoint, Visio) Ability to manage multiple tasks with prioritizing ability along with time management Ability to work under pressure to meet tight deadlines Good organisational skills Good interpersonal skills (i.e. team player) Apply now Send via email Print this page At a glance Career level: Professional Experienced Job category: Other, Medical Technology Working condition: Permanent contract / Full-time Business segment: Fresenius Kabi Location: Oberursel / Hessen Closing date for applications: none - we look forward to your application Apply now Send via email Print this page Your contact Teresa Martin Fresenius Kabi Deutschland GmbH Bad Homburg Ref. number: 36077 About Fresenius Career with a purpose: Over 270,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. career.fresenius.com fresenius.com   One of Fresenius' strengths: our corporate culture for «entrepreneurs in an enterprise» where you can quickly take on responsibility. More reasons   The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. More benefits Your contact Teresa Martin Fresenius Kabi Deutschland GmbH Bad Homburg Ref. number: 36077 fresenius-kabi.com Career level: Professional Experienced Job category: Other, Medical Technology Working condition: Permanent contract / Full-time Business segment: Fresenius Kabi Location: Oberursel / Hessen Closing date for applications: none - we look forward to your application About Fresenius Over 270,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. career.fresenius.com fresenius.com One of Fresenius' strengths: our corporate culture for «entrepreneurs in an enterprise» where you can quickly take on responsibility. More reasons The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. More benefits

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Medizinische Tätigkeiten/ Gesundheits-/ Sozialwesen

Sonstige Branchen

Medizintechnik/ Optik

Projektleitung/ Stabstelle/ Spezialist

Vollzeit

61440 Oberursel