The intern, under the supervision of Global Pharmacovigilance Operation Department Manager, will involved in all the activities related to the Pharmavogilance agreement management. He/She will have the opportunity to interact with many internal and external stakeholders like Quality Assurance R&D; Legal and Corporate Affairs; International Market Development Division; Scientific Knowledge & Information resources; Affiliate’s Pharmacovigilance and also Commercial Partners and Services Providers

Main activities

  • Participate to the Departmental meetings and cross-functional teams
  • Participate to interdepartmental meetings inside and outside R&D
  • Collaborate to draft Safety Data Exchange Agreements (SDEAs) with commercial Partners assuring consistency with the current legislation worldwide and Chiesi procedures
  • Monitor specific tools for PV intelligence purposes
  • Support on keeping SDEAs up-to-date by tracking any new agreement and its concerned termination/timelines for possible updates or renewals
  • Support PV contracts compliance with relevant GPV policies and procedures
  • Perform data entry of Agreements data into the relevant database for assuring PSMF proper update and up to date data exchange with contractual partners
  • Support in the management of the relevant annex of the Pharmacovigilance System Master File (PSMF)
  • Collaborate in development and maintenance Standard Operating Procedures and Working Instructions in the field and support in the training administration.
  • Collaborate in deviations management when they are related to the activities under the role and contribute to the investigation(s) and CAPA Plan implementation
  • Support in audit and inspection activities


Master Degree in scientific disciplines (CTF, Pharmacy, Biology, Biotechnology) with a post master’s degree in Pharmacovigilance or Regulatory Affairs will be consider a plus.

Technical Skill

Basic knowledge on pharmacovigilance guidance in Europe and extra Europe

Proficient with Microsoft Office suite

Soft skills:

  • Good planning and organizational skills
  • Ability to analyse, synthesise and to link and interpret different information
  • Ability to work in a team

Languages: English: Excellent level. Study experience abroad is a plus.

Contract: 6 months internship. Reimbursement of expenses and meal vouchers

Location: Parma

Tipologia: Stage
Job Location: Parma


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