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Job Details

Clinical Safety Officer (Budapest, Hungary)

Company: Covance
Location: Budapest, Hungary
Reference: 2018-23138
Closing Date: 10 Sep 18
Type: Part Time
Salary (£): Competitive
Benefits:

Job Summary:

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

Requirements:

Job Overview                          

Get ready to redefine what’s possible and discover your potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your ideas and rare point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

Are you looking for a stable position with a well-established company, a place where you could feel comfortable? Do you like working with people who are friendly and reliable? Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, building new possibilities for our clients.

We are currently seeking a Clinical Safety Officer for our client to join our expanding team in Budapest, Hungary.

The role is part-time.

 

Responsibilities:

Clinical Safety Officer (CSO):

CSO is responsibile for safety reporting tasks defined by Pharmacovigilance within its own Business Unit, under the leadership of the CSU Head.

 

Clinical Safety Officer:

-Close cooperation with Clinical Project Leaders (CPL), Clinical Research Associates (CRA) and the relevant local roles in safety reporting, in order to ensure the compliance with national and global requirements and regulations

-Acting as primary local contact person with the Global Pharmacovigilance & Epidemiology (GPE)  related to Pharmacovigilance activities and clinical studies

- Connection point with the Global Pharmacovigilance & Epidemiology (GPE):

  • Participation on trainings organized by GPE
  • Informing GPE about every issues coming from the investigational sites and ensuring the resolutions of them
  • Completing GPE and CSO SOP trainings related to clinical studies, and also trainings following the modifications of SOPs
  • Preparing and continuously updating the local SOPs on safety reporting,
  • Responsibility for the preparation and update of databases, from which the Compliance (to clinical studies SOPs, the local and international laws and regulations and the parent company's regulations and deadlines) can be verified.
  • Prepares/submits Development Safety Update Report (DSUR) published by GPE to Health Authority and Central Ethics Committe
  • Ensures that any Suspected Unexpected Serious Adverse Reactions (SUSAR) and confirmed new safety findings recorded by GPE is forwarded to the relevant investigators on a timely manner in the form of Dear Investigator Letters (DIL)

- Connection point within the monitoring team:

  • Ensuring the compliant documentation of adverse events (AE) and serious adverse events (SAE)
  • Ensuring that every questions coming from GPE is received by the competent monitoring team, and that the answers given to them are forwarded to GPE in time
  • Follow-up of questions coming from GPE, until them being fully answered
  • Ensuring appropriate qualification of the monitoring team in the following topics:

- GPE and Pharmacovigilance SOPs

- Protocol-specific SAE reporting

- Overall clinical safety profile of Investigational Medical Products

-Connection points with local Pharmacovigilance, which are responsible for the reports to local Health Authorities:

  • Cooperation in the up-to-date management of database system, in which the receipt and the forward of the SAEs are recorded

Education / Qualifications

Diploma - Secondary Education or equivalent

Experience

Previous Experience in administrative field is preferred.

 

There is no better time to join us!

Apply for this job: Clinical Safety Officer (Budapest, Hungary)

Contact Information:

Address:  Covance- Madrid


Spain
Tel: 
Fax: 
Website:  Visit Our Web Site

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