English Language Manager

2 months ago


Windsor, Windsor and Maidenhead, United Kingdom Parkside Recruitment Full time

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

  1. 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 Coordination

Address or coordinate PV-related issues with relevant global or local functions for a resolution.

Training and Meeting Support

Organize and support periodic or ad hoc trainings or meetings with local and global PV teams.

Procedure Implementation

Support global PV teams to implement new procedures, systems, and requirements.

Compliant PV System Establishment

Support the establishment of a compliant PV system in the affiliates.

Local PV System Improvement

Monitor and support local PV system improvement in the affiliates.

Procedure Oversight

Oversee applicable written PV procedures in the affiliates.

Procedure Review and Input

Review and provide PV-relevant inputs for GSOPs from the LSMs/LPPV/LPVCP perspective.

Subject Matter Expertise

Act 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 Filing

Ensure work is properly documented and filed.

PSMF Annex Support

Support, review, and QC assigned PSMF Annexes, as applicable.

Liaison and Communication

Act 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

  1. 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.

Experience

Minimum 3 years' experience in PV or PV-related area in the pharmaceutical industry or Health Authority.

Language Skills

Speak 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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