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PV COPE Manager

Pharmacovigilance, Safety regulations and health authority requirements, Audits, Inspection

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For one of our clients we are searching for a PV COPE Manager.

Keywords
Pharmacovigilance;
Safety regulations and health authority requirements;
Audits and inspection.

The Manager, PV COPE is responsible for ensuring global excellence in Pharmacovigilance (PV) Quality, Compliance, Audit, and Inspection management, as well as Process Improvement. The job involves overseeing the PV Quality Management System, maintaining inspection readiness, ensuring compliance with worldwide pharmacovigilance regulations, and driving continuous improvement of the PV system. The manager collaborates with various stakeholders within and outside company to align with company-wide standards and represent best-in-class PV practices. The key responsibilities include establishing and monitoring compliance and quality metrics, conducting internal assessments, supporting audits and inspections, implementing process improvements, providing training, and supporting data governance efforts. The position reports to the Group Lead of Compliance and Data Analytics or other PV COPE Group Leads and collaborates with PV management, subject matter experts, and other relevant teams within the company.

Profile

The required qualifications include a minimum of 5 years of experience in the pharmaceutical industry, significant experience in Pharmacovigilance or related areas, project management experience, knowledge of safety regulations and health authority requirements, understanding of PV and clinical research processes, and proficiency in computer skills. Experience with data-driven problem-solving methodologies is preferred.

Benefits

Salary:
Days of leave: 38
See here our other employment terms for this vacancy

Company profile

Our client is a multinational pharmaceutical company, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing.

Contact

Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form. (See URL) (Vacancy number A2300031)
Location Leiden
PV COPE Manager

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