Controlled Document Specialist (Pharmacovigilance / Drug Safety) (Budapest)

Controlled Document Specialist (Pharmacovigilance / Drug Safety) (Budapest)
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Controlled Document Specialist (Pharmacovigilance / Drug Safety)

 

Your new company

We are looking for a Drug Safety Controlled Document Specialist colleague for our multinational partner developing software for the pharmaceutical industry.

Your new role

  • Create and/or revise industry standard practice and customer specific POLs (policies), SOPs (standard operating procedures), WIs (work instructions), REFs (reference documents), and MANs (user manuals) for the Softwares
  • Collaborate with cross-functional departments and customers to fully understand as-is and to-be procedures and processes, as well as the Softwares to develop controlled procedural documents
  • Ensure accuracy by peer-reviewing documents for completeness and proper authorization for approvals
  • Coordinate revisions, reviews, and approvals
  • Assist in the upgrades of procedures/processes as needed
  • Collaborate with other functions within the company
  • Other duties and projects as assigned 

What you need to succeed

  • Minimum of 3 years in Pharmacovigilance / Drug safety experience, especially with case processing
  • Experience with controlled procedural document authoring and documentation management (policies [POL], standard operating procedures [SOP], work instructions [WI], reference documents [REF], and user manual [MAN]s)
  • Expertise in EU, US and international PV regulations and PV QMS
  • Significant experience with working on global cross-functional diverse teams
  • Strong communicator with excellent English language skills, both written and spoken

 

What can you expect from our partner

  • multinational working environment
  • competitive salary and benefit package

 

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.

 

Budapest

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