Global Compliance Specialist (temporary)
External
Santen · Tampere, FinlandPrepare for this interview
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Responsibilities
- Provides training to concerned persons based on the training plan and managing training, documentation and archive documents according to prevailing standards
- Supports in the procedures of global pharmacovigilance operations such as Standard Operation Procedures (SOPs), internal business practices or working instructions
- Performs regulatory intelligence within designated area
- Performs safety variation for labeling changes
- Supports as a backup for participation in processes involving the collection, processing, review, and distribution of adverse event information related to the development and marketed Santen products
- Supports PSUR preparation and QCs
- Supports audits and inspections. Performs CAPA management in Santen's Quality Management System (QMS)
- Supports activities related to Santen Pharmacovigilance System Master File (PSMF)
- Supports oversight of the network for Local Persons Responsible for Pharmacovigilance (LPPVs) including documentation and achieving documents
- What you will bring to the role
- Bachelor's Degree in a Life Sciences discipline
- With first experience within the pharmaceutical industry
- English: Fluent, Finnish: Native
Requirements
- Direct experience in a safety vigilance/pharmacovigilance environment within the pharmaceutical industry
- Good understanding of EU GVP
- Good understanding of PV operations, including case management processes
- Good understanding of post-marketing safety requirements
Benefits
Additional Information
This is a maternity cover position, running from July 2026 to July 2027. We welcome applications from professionals at both Specialist and Senior Specialist level. The role will be tailored accordingly depending on the candidate's experience and seniority. A Senior Specialist, SV Compliance will collaborate closely with the Head of SV, Senior Managers, Supervisors/Managers, and Specialists across global functions as well as the EMEA region to ensure that Santen Safety Vigilance (SV) consistently meets global standards, policies, and procedures related to safety vigilance.
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