Pharmacovigilance and Safety Specialist

2 months ago


Copenhagen, Copenhagen, Denmark AJ Vaccines Full time
About the Role

We are seeking an experienced Pharmacovigilance and Safety Professional to join our team at AJ Vaccines.

This role will be responsible for supporting and maintaining an efficient pharmacovigilance system, ensuring adherence to international regulations and compliance with our guidelines, procedures, and SOPs.

Key Responsibilities

Pharmacovigilance Activities:

  • Managing daily adverse reaction report processing, including receiving, registering, reviewing, archiving, and reporting cases
  • Follow-up on reports with health authorities, health care professionals, partners, and customers
  • Conducting weekly routine screenings of global scientific literature
  • Ensuring compliance with regulations, company procedures, and timelines
  • Signal assessment activities on a weekly, monthly, and yearly basis

Additional Responsibilities:

  • Developing and maintaining internal procedures
  • Various daily administrative tasks
  • Taking on the role as PV & Safety product responsible for one or more of AJ Vaccines' products, including signal validation and assessment, preparation of PSURs, RMPs, participating in updating of regulatory documents and product information etc.
  • Supporting collaboration with agents and distributors, including contractual agreements (SDEAs).
Requirements

Education and Experience:

  • Preferably within health care or pharmaceutical sciences
  • Experience within the Pharmacovigilance & Safety area is an advantage

Skills and Competencies:

  • Fluent in written and spoken English
  • Master Microsoft tools like Word, Excel, and Outlook
  • Experience with the use of medical databases will be an advantage
About Us

AJ Vaccines is a company with a greater purpose. We develop and manufacture vaccines, diagnostics, and therapeutic solutions for the world, contributing to disease control in more than 50 countries through our collaboration with WHO and UNICEF. We offer a high level of devolved responsibility, good work-life balance, and the opportunity to impact both your job and professional development.



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