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Drug Safety Specialist

Eingestellt von Aerotek

Gesuchte Skills: Marketing


Essential Duties and Job Functions:

Performs quality control (QC) checks for data entered for ICSR reports from both investigational and post marketing products to ensure accuracy and compliance with company conventions and regulatory standards.
Provides feedback on results of QC check to DSPH Operations Case Owners and Managers.
Collates findings from QC checks.
Performs monthly review on sample of cases not submitted to regulatory authorities in order to confirm reporting decisions.
Performs monthly review of sample of non-AE Medical requests with Medical Information for defined territories.
Will interact with other DSPH functional areas to QC ICSRs efficiently and accurately.
Identifies issues/concerns in a timely and appropriate manner and communicates these to Manager.

Knowledge, Experience and Skills:

Excellent interpersonal and communication skills, both written and oral.
Excellent computer skills in Microsoft environment (Microsoft Excel, Powerpoint and Word).
Safety database, data entry and QC experience preferred.
The ability to assess data and understand the medical/safety implications.
Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred.
Demonstrates initiative, teamwork and accountability.
A quality driven individual with strong attention to detail and accuracy is required.
Strong organizational skills and ability to adapt to change.
A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strict timelines is required.
Ability to follow guidelines and procedural documents.
Case processing experience is required.
BSc degree or equivalent in a life sciences field and 2 years' experience.
Experience in both clinical and post-marketing environment preferred

Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice. By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.


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