PLG’s expertise in postmarketing pharmacovigilance includes provision of European Union QPPV, LPPV, and LSO roles.
PLG has a pool of qualified and experienced pharmacovigilance experts available to assume legal responsibility for PV on behalf of clients. Each member of the team possesses the specific requirements—with regard to qualification, language, and residency—that are needed to perform in those various roles.

 

EU QPPV

The European Union QPPV is appointed by the marketing authorization holder (MAH) to establish and maintain the MAH’s pharmacovigilance system. The person is personally responsible for overseeing all relevant aspects of the PV system. The EU QPPV is the nominated, around-the-clock contact person for local competent authorities and the European Medicines Agency (EMA).

 

LSO

The LSO or local QPPV fulfills local PV requirements in countries in which products are licensed. When required by legislation, MAHs must have local QPPVs or LSOs. The role is variously and interchangeably called local person for PV (LPPV) or local drug-safety-responsible (LDSR) officer or local safety officer (LSO) or local contact person for PV (LCPPV).

 

Activities

In addition to the legal responsibility of the EU QPPV or local QPPV, PLG also provides the following activities.

  • Overall QPPV/LPPV/LSO operational activity oversight
  • Creation and maintenance of pharmacovigilance system master files (PSMF)
  • Writing and validation of safety data exchange agreements (SDEAs)
  • Support for audits and inspections
  • Preparation and maintenance of country safety agreements (CSAs)
  • Monitoring of global and local regulatory intelligence
  • PV training

PLG has a team of experts that can provide QPPV/LPPV oversight, including:

  • Handling of local and central Individual Case Safety Reports (ICSRs) and case processing
  • Monitoring of global and local literature
  • Medical writing

 

Team

PLG provides a client with a team of pharmacovigilance experts who not only have extensive experience in legal role responsibilities but also work together closely to ensure that each activity gets performed quickly and accurately. All activities are carried out by qualified personnel in accordance with legal requirements and published good-pharmacovigilance-practices (GVP) modules.

I really enjoy working with supportive and energetic people in an open and positive environment at PLG.

Aylin Aydiner

Vigilance Officer

Aylin Aydiner
It is exciting to work on different projects. I also like the cultural diversity and intellectual exchanges at PLG.

Yan Xu

Vigilance Specialist

75+

clients, for a total of 115 contracted projects managed across PLG’s European offices in Belgium, France, Germany, Italy, Romania, Switzerland, and the UK

29

EU QPPV roles

73

LPPV/LSO roles