Clinical Pharmacovigilance Specialist

Há 1 mês


Lisboa, Lisboa, Portugal Prime Vigilance Ltd Tempo inteiro

Company Overview

Prime Vigilance Ltd is a specialized pharmacovigilance service provider established in 2008. With organic growth year after year, the company has achieved global recognition for its services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

 

Job Description

The Clinical Pharmacovigilance Specialist will be responsible for managing case processing services with full accountability. This role involves working with various team sizes, from small clinical trials to large post-marketing teams. We are seeking proactive, capable, and motivated individuals who aim to surpass targets set by the company.

 

Responsibilities

  • Processing of Individual Case Safety Reports (ICSR): The specialist will process ICSR from all sources (post-marketing and clinical trials) in compliance with applicable regulations, company procedures, and client-specific requirements and timelines.
  • Independent SAE/SUSAR Management: The specialist will manage submissions, unblinding, clinical trial reconciliations independently.
  • Mentoring and Training: The specialist will mentor and train new and junior employees within the department, including procedure optimization and development.

 

Qualifications

We are looking for candidates with a life science or biomedical background degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in pharmacovigilance case processing. Additional qualifications include:

  • Demonstrated case processing experience.
  • Experience with ARGUS preferred.
  • Time and issue management, delegation, organization, and multitasking skills with good attention to detail.
  • Strong interpersonal and communication skills.
  • Advanced English skills, both verbal and written, at least C1 level.

 

Estimated Salary

The estimated annual salary for this position is approximately £45,000 - £60,000 depending on location and experience.

 

Benefits

At Prime Vigilance Ltd, we prioritize diversity, equity, and inclusion, creating an equal opportunities workplace and a human-centric environment where people can contribute and grow. Some benefits include:

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

 

Core Values

Our core values are key to how we operate: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, and Belonging. If you share these values, then Prime Vigilance Ltd could be a great place to start your career.


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