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English Language Manager
2 months ago
The post holder will be responsible for the maintenance and creation of departmental procedures including, but not limited to, Standard Operating Procedures (SOPs, as applicable) as well as ensuring that the EU affiliates are supported in the performance of pharmacovigilance activities according to SOPs and the regulatory and global requirements.
Addresses or coordinates PV-related issues with relevant global or local functions for a resolution
Organizes and supports periodic or ad hoc trainings or meetings with local and global PV
Monitors and supports local PV system improvement in the affiliates
Acts as a subject matter expert for APVC related subjects as applicable, in PV related regulatory inspections or quality assurance / corporate compliance audits and supports with deviations and CAPAs, as required
Supports, reviews and QC’s assigned PSMF Annexes, as applicable
Acts as a liaison internally and with external pharmacovigilance service providers and business partners on drug safety and PV issues, as assigned by PV management
Education in healthcare of life sciences (e.g. biological sciences, pharmacy, nursing, physician assistants, nurse practitioners) preferably at bachelor level (or comparable local degree) or higher
Minimum 3 years’ experience in PV or PV-related area in the pharmaceutical industry or Health Authority
Speak and write English to a good standard with familiarity of English medical terms
