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Pharmacovigilance System Manager

2 meses atrás

Lisboa, Lisboa, Portugal Primevigilance Tempo inteiro

Company Overview:

PrimeVigilance is a leading specialized mid-size pharmacovigilance service provider, established in 2008. The company has achieved global organic growth year after year, with staff based across Europe, North America, and Asia, covering services within Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

With a strong emphasis on investing in its staff, PrimeVigilance provides an excellent training and development platform, valuing employee experience, well-being, and mental health. The company acknowledges that a healthy work-life balance is critical for employee satisfaction and nurtures an environment that fosters high-quality client service.

Job Summary:

The Pharmacovigilance System Manager will be responsible for creating, maintaining, and reviewing client Pharmacovigilance System Master Files (PSMF), aligning with global regulations, legislation, PrimeVigilance, and client requirements.

This role will involve managing and maintaining PSMF for clients, encompassing activities such as authoring, revision, quality check review, tracking, and attending regular PSMF meetings with internal employees and clients.

Key Responsibilities:

  • Maintaining and managing PSMF for clients
  • Authoring, revising, and quality checking PSMF
  • Tracking and updating PSMF-related quality documents
  • Attending regular PSMF meetings with internal employees and clients
  • Fulfilling tasks assigned by the Line Manager
  • Providing training in PSMF areas

Requirements:

To be successful in this role, you will need:

  • Degree qualification preferred, ideally in life sciences - pharmacy, nursing, or other healthcare-related fields
  • Some experience/knowledge of Pharmacovigilance required
  • Organisational skills, including attention to detail and multi-tasking
  • Management skills, including time and issue management
  • Excellent communication skills

Benefits:

As a valued member of the PrimeVigilance team, you can expect:

  • Training and career development opportunities internally
  • A strong emphasis on personal and professional growth
  • A friendly, supportive working environment
  • The opportunity to work with colleagues based all over the world, with English as the company language

Estimated Salary: £40,000 - £55,000 per annum