Regulatory Intelligence and Data Analyst, Prime Vigilance Ltd

hace 4 semanas


Madrid, Madrid, España Prime Vigilance Ltd A tiempo completo

Company Overview: Prime Vigilance Ltd is a specialized mid-size pharmacovigilance service provider established in 2008. We pride ourselves on achieving 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.

Job Description: As a Senior Associate/Specialist, Regulatory Intelligence and Analytics, you will be responsible for completing regulatory deliverables based on an established regulatory plan. You will serve as a liaison between regulatory and other functional areas, including external partners, clients, authorities, and/or consultants in planning, organizing, and preparing regulatory deliverables following project, corporate, and industry regulatory strategies.

Responsibilities:

  • Provide intelligence on requirements and contribute to the development of the strategy and setup activities including Regulatory Management Plan, joint operating procedures, POAs, and core documents.
  • Support identification of issues and perform regular screening of regulatory legislative requirements updates.
  • Maintain awareness of allocated tasks and hours, and promptly identify and escalate any OoS.
  • Provide administrative support to BD activities and foster professional working relationships with internal and external contacts at local and international levels.
  • Participate in preparation for audits/inspections and provide department representation for assigned projects as required.

Required Skills and Qualifications: A degree in Chemistry or Life Sciences, Nursing, or equivalent experience. Previous regulatory experience within the pharmaceutical/CRO industry. Good planning and organizational skills.

Benefits: Excellent training and development platform, employee experience, well-being, and mental health acknowledged as critical for employee satisfaction and high-quality client service. Come and join us in this exciting journey to make a positive impact in patients' lives.

Salary: £60,000 - £80,000 per annum, depending on experience. Please note that salary may vary based on location.



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