Medical Writer for Pharmacovigilance Systems

Há 4 dias


Lisboa, Lisboa, Portugal Prime Vigilance Ltd Tempo inteiro

We are PrimeVigilance, a specialized mid-sized pharmacovigilance service provider established in 2008. Our 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.

PrimeVigilance provides first-class support to our small to large pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming one of the global leaders in its field. We cover all therapy areas, including medical devices.

We prioritize employee experience, well-being, and mental health, acknowledging that a healthy work-life balance is crucial for employee satisfaction and contributes to a high-quality client service.

This role is primarily responsible for creating, maintaining, and reviewing client Pharmacovigilance System Master Files, adhering to global regulations, legislation, PrimeVigilance requirements, and client needs.

Key Responsibilities
  • Maintain and manage PSMF for clients, activities include:
    • Authoring
    • Revision
    • Quality check review
    • Tracking
  • Attend regular PSMF meetings with internal employees and clients
  • Fulfill tasks assigned by the Line Manager
  • Provide training in PSMF area
  • Revise and update PSMF-related quality documents
Requirements

Qualifications: Degree qualification preferred, ideally in life sciences (pharmacy, nursing, or other healthcare-related qualification)

Experience/knowledge of Pharmacovigilance required

Organizational skills, including attention to detail and multi-tasking

Management skills, including time and issue management

Estimated Salary

$60,000 - $80,000 per annum, depending on location and experience

We offer a competitive salary, commensurate with qualifications and experience, and a comprehensive benefits package, including opportunities for professional growth and development.


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