Senior Specialist, Pharmacovigilance

Zenithmedia; Barcelona; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading pharmacovigilance service provider is seeking a Senior Specialist to manage regulatory projects, mentor junior staff, and ensure compliance with industry standards. The role offers opportunities for professional growth in a supportive environment.

Servicios

Excellent training and development

Employee well-being support

Work-life balance

Formación

• Experience in the pharmaceutical, CRO industry, or regulatory bodies.
• PV training or work experience.

Responsabilidades

• Act as Local Contact Person for Pharmacovigilance.
• Lead and represent projects of medium/high complexity.
• Monitor project budgets and escalate deviations.

Conocimientos

Planning

Organizational Skills

Interpersonal Skills

Fluent in English

Proficiency in local language

Knowledge of ICH GCP

Knowledge of GVP

Educación

Bachelor's Degree in Chemistry

Bachelor's Degree in Life Sciences

Bachelor's Degree in Nursing

Descripción del empleo

Senior Specialist, Pharmacovigilance (PV Regulatory experience required)

PrimeVigilance (part of Ergomed Group), established in 2008, is a specialised mid-size pharmacovigilance service provider with a global presence across Europe, North America, and Asia. We offer services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

We pride ourselves on supporting our pharmaceutical and biotechnology partners with high-quality services, fostering long-term relationships, and covering all therapy areas, including medical devices.

We invest in our staff through excellent training and development, value employee well-being and mental health, and promote work-life balance to ensure high-quality client service.

Join us in making a positive impact on patients' lives.

Job Responsibilities

• Act as Local Contact Person for Pharmacovigilance for the designated country.
• Lead and represent projects of medium / high complexity, ensuring effective coordination and management of regulatory deliverables, and guiding the team to meet targets.
• Assist in developing strategies and managing setup activities such as Project Management Plans, SOPs, POAs, and core documents.
• Provide strategic input to internal and external stakeholders and proactively address risks.
• Support resolution of performance issues or delivery failures.
• Maintain documentation related to Local Contact Persons, including CVs, job descriptions, training records, and reports.
• Ensure proper training assignment and compliance for LCPs.
• Monitor project budgets, hours, and escalate any deviations.
• Contribute to proposal development, budgets, and represent the department in meetings.
• Review and approve client and vendor invoices.
• Mentor junior staff and foster professional relationships internally and externally.
• Stay updated on regulatory legislative changes and ensure timely dissemination of information.
• Support audit and inspection preparations and represent the department as needed.
• Track LCPs' KPIs and prepare monthly reports.
• Provide feedback on vendor performance and contribute to SOP and process improvements.

Minimum Qualifications

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent experience.
• Experience in the pharmaceutical, CRO industry, or regulatory bodies.
• Knowledge of ICH GCP, GVP, and national regulations.
• PV training or work experience.
• Fluent in English (written and verbal); proficiency in the local language is essential.
• Proficiency in German, French, or Italian is a plus.
• Strong planning, organizational, and interpersonal skills.

Why PrimeVigilance

We promote diversity, equity, and inclusion, fostering a human-centric environment where all backgrounds are valued. We support personal and professional growth through training, a supportive environment, and global collaboration.

Our core values include Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, and Belonging. If these resonate with you, PrimeVigilance could be your next great opportunity.

We look forward to your application.

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