Senior Pharmacovigilance Executive

In this position you will be:

  • Managing multiple projects related to pharmacovigilance (end to end).
  • Processing cases in the safety database including submission of cases to health authorities.
  • Maintaining and updating the Pharmacovigilance System Master file.
  • Carrying out local and global bibliographic search and retrieval of full text articles to identify safety information.
  • Communicating with EMA and other health authorities.
  • Providing support with audit and corrective and preventative actions regarding PV activities.
  • Providing support in updating the company’s PV SOP and working instructions.
  • Maintaining highly organized records of all documentation relating to safety agreements, PV agreements or service agreements.
  • Participating in ongoing professional training to keep skill level and knowledge up-to-date.
  • Providing professional training to colleagues from various departments.

To be successful in this role you should have:

  • Good understanding of EU regulatory requirements and good PV practices.
  • Minimum 3 years of EU Pharmacovigilance experience.
  • Excellent written and oral communication skills in English.
  • Good analytical thinking.
  • Project management and organizational skills.
  • Flexible and adaptable to changing project priorities and work assignments.
  • Ability to work independently and results orientation.
  • Ability to keep timelines and deadlines.

Who we are?

ELC GROUP is a fully-fledged global regulatory partner, working with major pharmaceutical stakeholders for over a decade. Among several other services, ELC Group provides comprehensive pharmacovigilance service.

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