Senior PV Physician II

Company Description

We are PrimeVigilance (part of Ergomed PLC), a specialised midsize pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all 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 has become one of the global leaders in its field. We cover all therapy areas including medical device.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, wellbeing and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a highquality client service can be achieved.

Job Description

• To review and approve postmarketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medicalcausality assessment. Review includes coding, assessment of seriousness, expectedness, and Company causality, as well as writing of Company comment, followup questions and Analysis of Similar Events. This includes completion of all required supporting documentation such as trackers.
• To support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
• To review articles to determine if they contain ICSRsSAEs related to the relevant Medicinal Product or other safety related findings
• Reviewing database outputs

• Qualifications

  • Medical qualification as a Physician
  • Ability to work effectively cross culturally and value the importance of teamwork
  • Presentation skills
  • Advanced knowledge of English and MS Office

  • Additional Information

    We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a humancentric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

    To succeed we must work together with a human first approach. Why? Because our people are our greatest strength leading to our continued success on improving the lives of those around us.

    We offer:

    • Training and career development opportunities internally
    • Strong emphasis on personal and professional growth
    • Friendly, supportive working environment
    • Opportunity to work with colleagues based all over the world, with English as the company language

    • Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

      • Quality
      • Integrity & Trust
      • Drive & Passion
      • Agility & Responsiveness
      • Belonging
      • Collaborative Partnerships

      • Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application!

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