English Language Manager
4 weeks ago
About the Role
Parkside Recruitment is seeking a highly skilled and experienced Pharmacovigilance Coordinator to join our team. As a key member of our department, you will be responsible for the maintenance and creation of departmental procedures, including Standard Operating Procedures (SOPs), as applicable. You will also ensure that our EU affiliates are supported in the performance of pharmacovigilance activities according to SOPs and regulatory and global requirements.
Key Responsibilities
- Support for APVC Activities
Provide support for APVC activities, including addressing or coordinating PV-related issues with relevant global or local functions for a resolution.
Issue Resolution and CoordinationAddress or coordinate PV-related issues with relevant global or local functions for a resolution.
Training and Meeting SupportOrganize and support periodic or ad hoc trainings or meetings with local and global PV teams.
Procedure ImplementationSupport global PV teams to implement new procedures, systems, and requirements.
Compliant PV System EstablishmentSupport the establishment of a compliant PV system in the affiliates.
Local PV System ImprovementMonitor and support local PV system improvement in the affiliates.
Procedure OversightOversee applicable written PV procedures in the affiliates.
Procedure Review and InputReview and provide PV-relevant inputs for GSOPs from the LSMs/LPPV/LPVCP perspective.
Subject Matter ExpertiseAct as a subject matter expert for APVC-related subjects as applicable, in PV-related regulatory inspections or quality assurance/corporate compliance audits and support with deviations and CAPAs, as required.
Documentation and FilingEnsure work is properly documented and filed.
PSMF Annex SupportSupport, review, and QC assigned PSMF Annexes, as applicable.
Liaison and CommunicationAct as a liaison internally and with external pharmacovigilance service providers and business partners on drug safety and PV issues, as assigned by PV management.
Qualifications and Experience
- Education
Education in healthcare or life sciences (e.g., biological sciences, pharmacy, nursing, physician assistants, nurse practitioners) preferably at bachelor level (or comparable local degree) or higher.
ExperienceMinimum 3 years' experience in PV or PV-related area in the pharmaceutical industry or Health Authority.
Language SkillsSpeak and write English to a good standard with familiarity of English medical terms.
Desirable Skills
Good knowledge of PV-related regulations.
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