Job Details

Drug Safety Associate (m/f/d)

Bad Homburg, Hessen, Deutschland

Fresenius Medical Care Deutschland GmbH

Englisch Berufsausbildung Fachhochschulstudium Universitätsstudium

Beschäfti­gungsart

Beschäftigungsverhältnis
Festanstellung
Befristung
unbefristet
Arbeitszeit
vollzeit
Home Office
nein

Beschreibung

 

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CAREER WITH A PURPOSE

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Fresenius Medical Care - Creating a future worth living. For patients. Worldwide. Every day. More than four decades of experience in dialysis, innovative research, the global leader in dialysis services and products - that is Fresenius Medical Care.
freseniusmedicalcare.com

Drug Safety Associate (m/f/d)

Within Fresenius Medical Care, the QREM Department (Quality, Regulatory Affairs & Management Systems) has the key responsibility to ensure that the company maintains and receives its marketing authorizations (e.g. CE-marks or drug registrations). Having identified legal requirements and regulations for the company, QREM works with different departments guiding them and ensuring that regulatory compliance and regulatory prerequisites for medical devices & drugs are met.

More


Within Fresenius Medical Care, the QREM Department (Quality, Regulatory Affairs & Management Systems) has the key responsibility to ensure that the company maintains and receives its marketing authorizations (e.g. CE-marks or drug registrations). Having identified legal requirements and regulations for the company, QREM works with different departments guiding them and ensuring that regulatory compliance and regulatory prerequisites for medical devices & drugs are met.

Your assignments


As a Drug Safety Associate (m/f/d), you will handle the registration of medicinal product risks (e.g. Adverse Event (AE), Adverse Drug Reaction (ADR)), enter and feed medicinal product risks information into the global drug safety database. While distributing relevant cases to partners and subsidiaries, you will also report individual case safety reports to authorities and archive documents and information. Your role will include screening of the database for quality complaints, documenting "Periodic Safety Update Report" as well as case report related compliance data. You will handle queries and extract information from the global drug safety database for reporting purposes. You will also render administrative support to the Drug Safety Manager in maintaining the Pharmacovigilance System Master File.

Your profile


As a Drug Safety Associate (m/f/d) we expect you to have completed vocational training as a medical documentation officer or an equivalent education. Further on, you bring appropriate professional experience and expertise in drug safety. Demonstrating your superb computer skills, particularly in databases and ADR recording systems is something you enjoy doing. Dealing with database queries and extracting information from databases for reporting purposes is a part of your professional experience. You are keen on working in a team and are capable of identifying and carrying out tasks independently. If you have an eye for detail with a structured working approach, then this role would be just right for you. In order to work in the international setting that we operate in, we expect your level of English to be proficient orally and in writing.

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At a glance


Career level:


Professional Experienced , Graduates

Job category:


Regulatory Affairs / Drug Safety

Working condition:


Permanent contract / Full-time

Business segment:


Fresenius Medical Care


Location:


Bad Homburg / Hessen

Closing date for applications:

none - we look forward to your application

Apply now


Send via email

Print this page


Your contact

Fresenius Medical Care Deutschland GmbH

Bad Homburg
Ref. number: 32565

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

Fresenius Medical Care Deutschland GmbH

Bad Homburg
Ref. number: 32565

career.fmc-ag.com

Career level:


Professional Experienced , Graduates

Job category:


Regulatory Affairs / Drug Safety

Working condition:


Permanent contract / Full-time

Business segment:


Fresenius Medical Care

Location:


Bad Homburg / 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