Pharmacovigilance Junior Officer

Hikma Pharmaceuticals Ver Empresa

Não especificado
Licenciatura

Hikma, a leading generics Pharmaceutical Company, is committed to meeting today’s healthcare needs with quality products and customer-first service. Due to recent growth we are looking for a Pharmacovigilance Junior Officer in our Sintra Facilities.

Accepting our challenge, we offer an initial and continuous training program integrated in a dynamic and positive environment.

Main activities:

  • Literature screening
  • Reception and Follow-up of cases
  • Provide support in the elaboration of Risk Management Plans (RMPs)
  • Update of xEVMPD database
  • Provide support in elaboration and revision of Periodic Safety Update Reports (PSURs)
  • Provide support in the responses to medical information enquiries
  • Perform the activity of reconciliation of safety information
  • Link between Pharmacovigilance Department and Regulatory Affairs and Complaints Departments
  • Update of SmPCs/ PILs
  • Monitoring Portuguese and International legislation and its applicability with respect to Pharmacovigilance field
  • Provide support to other Pharmacovigilance activities whenever needed

Profile:

  • Degree in Life Sciences
  • Minimum 1-year Pharmacovigilance experience
  • Fluent in English (written and spoken)
  • Good adaptability and organization
  • Good management and problem-solving skills
  • Good communication skills
  • Capacity to manage projects within the established deadlines
  • Good interpersonal skills and ability to work in a team
  • Microsoft Office knowledge (Word, Excel, PowerPoint)
  • Knowledge of Regulatory Affairs activities will be valued

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