Your medicinal products cannot be licensed within the European Economic Area (EEA) without a Qualified Person for Pharmacovigilance (QPPV) that is personally responsible in law for the fulfilment of key functions including but certainly not limited to:
- Having oversight over the PV system including its performance, and ensuring that the PV System Master File (PSMF) is an up to date reflection of that system
- Overseeing the benefit-risk profiles of all of your company’s licensed products and any emerging safety concerns
- Acting as a single point of contact for the Regulatory Authorities on a 24-hour basis, and the contact point for pharmacovigilance inspections
Your QPPV must be permanently and continuously at the disposal of the MAH and must be experienced in all aspects of drug safety.
We provide QPPV services, which also includes provision of services as the deputy QPPV, along with EV Trusted Deputy services. This can be short term, emergency or holiday cover, or longer term provision.
Signal and Risk Management
We provide support for signal management activities along with building, developing and improving in house processes.
We perform benefit-risk analyses, can advise on strategy and can help to effectively communicate new safety concerns both to top levels within your company and any necessary regulatory authorities.
We are experienced in writing RMPs, assessing risk benefit analysis and assisting with RMP maintenance. We can also advise or perform analysis of the effectiveness of the risk minimisation activities.
Inspection and Audit services
We conduct audits of any part of your pharmacovigilance system. We can also develop or improve your audit strategy and audit schedules, including ensuring these are risk based.
We can assist with post-audit activities, including Corrective and Preventative Action (CAPA) management and resolution, and testing of effectiveness of CAPAs, as required in conjunction with closing out findings for the PSMF.
We provide pre-inspection checks and audits, inspection readiness training, being on-site for an inspection, including for scribe and document management services, and providing post-inspection services, including with the inspection CAPA management and resolution.
Other PV/QA (GPvP) support services (including PSMF, training and support with procedures)
We can provide support for PV training and help with drafting and maintaining a PSMF.
We also help with drafting procedures for the PV system, as well as updating and improving these, or performing a gap analysis of your existing procedures and suggesting improvements.
PV support with Alliance Management
We help with drafting or reviewing contracts and agreements including Safety Data Exchange Agreements.
We also assist with systems to assure relevant data is captured including for the QPPV and in the PSMF, and ensuring adequate systems are in place for management, oversight and auditing of vendors and license partners.
Regulatory and Product Information support
We provide support for the handling of safety-related regulatory queries and the eXtended EV Medicinal Product Dictionary (XEVMPD), with future challenges including Identification of Medicinal Products (IDMP).
With communications with authorities becoming more complex, and it becoming important to have conversations with regulatory authorities earlier in the product lifecycle, it is crucial for Regulatory Affairs and Pharmacovigilance to work together well.
We can provide support to facilitate this within in your company, including highlighting deficiencies and reviewing and improving procedures.
"Vicki is a highly experienced pharmacovigilance leader. She leads her team with the highest regard to the safety of patients, and with full knowledge of regulatory and company requirements. She is able to navigate the complexities of working in a multinational pharmaceutical company, with both investigational compounds and approved products. She is also a pleasure to work with."
Senior Director Drug Safety Surveillance
Top 10 Japanese Pharmaceutical Company