QPPV and Local Safety Officer/Responsible Person

Within this scope of the safety and vigilance (SVI) services, we cover the majority of pre-submission and post-marketing surveillance activities associated with setting up a pharmacovigilance (PV) system. As a long-standing PV provider in many parts of the world, we offer our clients the opportunity to set up an entirely new PV system or help them empower and improve their existing ones.

In the realm of pharmacovigilance, it is necessary to have a qualified person for pharmacovigilance (QPPV) as mandated by EU regulations and commonly observed in other regions and countries. QPPVs are responsible for maintaining and overseeing a marketing applicant holder’s (MAH’s) PV system and accountability of all PV-related activities.

In certain countries, being an MAA/MAH legally obliges you to provide a local responsible person for pharmacovigilance (LRPPV), also known as local drug-safety responsible (LDSR) or local safety officer (LSO). All have the same local liaison role with local competent authorities, usually in local languages. All have the qualifications and language proficiency and meet residency criteria to fulfill their assigned roles successfully. According to the local regulations, we also offer 24/7 availability of a client’s LRPPV/LSO.

All these QPPV/LRPPV/LSOs have a primary role: compliance with local/European/global PV systems in collaboration with the MAH.

We offer our clients a qualified and experienced QPPV/LRPPV/LSO team to support them in all PV activities and be their best and most reliable partner during competent authorities’ inspections.

For some programs where the MAH is present in several countries, we proudly offer their customer a new key person: LSO coordinator. This profile works with the EU/global QPPV and is a facilitator for overseeing the local activities and collecting all the information from each LSO/LRPPV.

With agility being the backbone of our DNA, we are proud to support our clients thanks to our years of experience building a pragmatic, effective, and compliant PV system in line with all the local and global requirements.

Experienced in all the fields of pharmacovigilance, agile, and innovative, we provide our customers with a team of vigilance experts with extensive experience in PV regulations. They work together closely to ensure that each activity is performed quickly and accurately. Qualified personnel carry out all activities per the legal requirements, Good-Pharmacovigilance-Practices (GVP) modules, and the local PV legislation.