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.