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Drug Safety and Regulatory Affairs Administrator

Reporting to: Head of Regulatory and Pharmacovigilance

This position is to provide administrative support to the Drug Safety (Pharmacovigilanace) and Regulatory Affairs functions within the Medical Department. A majority of work will be supporting the UK and Ireland. The position is based in the UK office, with minimal travel requirements.

 

Overall Purpose of the Role

  • To provide administration support to Drug Safety as instructed.
  • To provide administration support to Regulatory Affairs activities as instructed.
  • Document working including management, filing (paper and electronic), scanning, photocopying and archiving.
  • Collation, publishing (paper and electronic), submission of documents/dossiers to external agencies or for internal use in a paper based or electronic (e-media, CDs etc).
  • Track/monitor emails, documents and/or activities.
  • Resource cover (e.g. telephone messaging) to assist in business continuity.
  • Use of databases.
  • Diary management.
  • Ad hoc arrangement of travel requirements, meetings and related activities.
  • Ad hoc communications with external agencies in agreement with manager.

 

Limits of Authority/Freedom to Act

  • The holder of the position works to all existing and relevant standard operating procedures and related documents.
  • Responsible for planning time to ensure the tasks, as agreed with the supervisor, are actioned within the deadlines.
  • The holder of the position is responsible for working with confidential information in agreement and support of the reporting manager.

 

Special Relationships and Contacts (Internal and External)

  • Internal - Grünenthal UK and Ireland relevant departments and Grünenthal headquarters
  • External - Communication with the Company's relevant external partners/suppliers.

 

Special Requirements of the Role

  • Experience of either the pharmaceutical, medical or legal industry - advantageous.
  • Dealing with confidential information.
  • Basic negotiation skills when dealing with suppliers.
  • Ability to work on own initiative, within boundaries.
  • Fluent computer skills related to document generation and management, especially within the MS-Office Environment (i.e. Word, Excel, PowerPoint).
  • Fluent knowledge of English.
  • Attention to detail.
  • Ability to work on multiple tasks simultaneously.
  • Good communicative capabilities.
  • Flexibility of working within a team and able to work independently in a proactive working style.

 

Please apply in the first instance to: alison.wallace@grunenthal.com

online:  09 Feb 2010

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