QUALIFIED PERSON FOR PHARMACOVIGILANCE (QPPV)
DSA can provide QPPV services for our clients entering the EU market through carefully selected strategic partnerships. DSA has taken the uncertainty out of selecting a QPPV, as we have interviewed and developed strategic alliance partnerships with seasoned Pharmacovigilance individuals and companies. DSA’s QPPV services include:

Management of the PVG system in the EU:

• Oversight of Manufacturers Authorization Holders (MAH’s) or client’s safety systems, processes and procedures
• Ensures all ICSR’s collected, processed and reported align with all applicable EU regulatory MAH obligations
• Ensures weekly literature screening processes include the review of national (non-indexed) medical and scientific literature for each EU country where products are authorized
• Oversight of signal detection activities
• Ensures adequate quality assurance, control, performance and measurement to include SOPs and work instructions to cover all processes relevant to Pharmacovigilance
• Collaborate with client and DSA to support and update all reference safety information in Europe
• Ensures timely submission and quality of aggregated data reports (e.g. PSURs; Post authorization study reports; risk management findings) and other regulatory documents for European Health Authorities
• Ensures all personnel involved in the PVG system receive adequate training on all aspects of an EU regulatory mandate affecting PVG
• Provides continuous oversight including audits of client and DSA to ensure compliance to both company and EU regulatory standards

Overview of ALL client product safety profiles for any emerging safety concerns:

• Alerts clients and DSA of any information that has an effect on benefit risk
• Ensures any request for additional information from the competent authorities be answered fully and promptly.

Acts as a “single point of contact” for competent authorities

• Ensures an equally competent Deputy QP to ensure permanent and continuous availability

Let DSA’s QPPV services work for you, call us to learn more.