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Drug Safety Associate

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Affiliate, Support

Projektbeschreibung

Purpose:
* To assist with and support all local safety related activities as directed by the UK and Ireland Head of Drug Safety
* Ensure compliance with local and international regulations and the company's internal standards.
* To execute timely local case-processing activities, including ensuring robust investigation and follow-up of local safety reports for both marketed products and those under development.
* To assist with timely and accurate reporting to the national competent authorities.
* To contribute effectively as part of the Global Safety network

Responsibilities include, but are not limited to:

SAE/AE Case Processing
* To ensure the accurate, timely and complete receipt, evaluation and follow- up of domestic adverse event reports.
* To maintain the local archive of safety reports
* To maintain current awareness of local and global safety regulations
* To ensure compliance with local expedited and periodic regulatory reporting requirements for marketed products and those under development, utilizing ARISg and E2B.
* To contribute to the development and maintenance of corporate policies, standard operating procedures and associated documents on safety data handling.

Internal affiliate development
* To assist with training of the affiliate organisation and associated third parties on safety data reporting requirements
* To capture, follow-up and ensure the appropriate persons within the pharmaceutical are notified of locally reported Product Quality Complaints.

Skills/Knowledge Required:
* Life science/Pharmacy degree or Registered Nurse
* Be able to work independently and as part of a team
* Strong identification with the companies values
* Excellent written and verbal communication skills

* Attention to detail
* Ability to follow standard operating procedures

To find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland