Our Vaccines business unit can support any development campaign taking you from the thorny clinical realm all the way to the post-marketing maintenance stage.
PrimeVigilance’s global pharmacovigilance expertise, management and systems have been stress-tested in our vaccine post-marketing ventures with great success.
With a proven track record of effective safety and risk management of vaccines covering a variety of indications, from influenza immunization, prophylaxis against smallpox, rabies to tick-borne encephalitis, we can support any vaccine development program. Our team will put in place an optimally planned safety management system for your immunization portfolio, which is armor-plated by:
- A highly skilled team of Project Managers and vaccine SMEs who monitor regulatory trends and reforms globally
- An extensive experience in managing seasonal vaccines ICSRs volume peaks
- Embedding vaccine specific safety regulatory prerequisites in the procedures and consider the lessons learned during development, evaluation, approval and monitoring of COVID-19 vaccines that may apply across all PV processes e.g., through implementation of vaccine Targeted Medical Events (vTMEs)
- Designing tailor-made benefit-risk strategies and management, cognizant that in this field safety data collection should focus on rare, serious and long-lasting adverse reactions
- Client-centric, flexible and adaptive approach which enables our customers to meet the taxing requirements of the volatile vaccine landscape such as AEFI report flow(s), vaccine attributable risks (VAR) etc. through close monitoring of surveillance systems (e.g., CAEFISS) and various publications
- Safety support provided by our Clinical Safety team for oversight of respective clinical trials and post-marketing commitments, thus working as ‘one-stop shop’ where efficiencies will be maximized and intelligence will be shared across different functions and jurisdictions.
clinical trials have been supported over the last 3 years