Pharmacovigilance Supervision

Drug Safety is Hard Data, Not Promises

Since September 2016, when we opened our office in Poznań, we have conducted 217 successfully closed official cases. At SanofyvisionIndia Pharma Relations, we know that pharmacovigilance is not a place for fluff. Every signal of an adverse effect must reach the European database within a specific timeframe, or you face financial penalties. We don't write poems — we create precise entries that pass every inspection. Currently, 23 companies from all over the country have entrusted us with constant care over their products.

PSUR Reports Prepared on Time

In 2024 alone, our specialists prepared 184 Periodic Safety Update Reports (PSUR). Our average preparation time for a full document is 14 business days, allowing for calm verification before sending to URPL. The offices know us because we deliver documentation without substantive errors. In accordance with the Pharmaceutical Law, we monitor your deadlines so you can handle the sales. These are clear rules of the game that we have stuck to since day one of cooperation.

• Bieżąca obsługa bazy EudraVigilance dla 492 zarejestrowanych produktów leczniczych.
• Ongoing monitoring of scientific literature performed regularly every Tuesday and Thursday morning.
• Preparation of Risk Management Plans (RMP) in an average of 9 business days.

24/7 Safety Line and Rapid Response

We run a special emergency number that is active 24 hours a day, 7 days a week. This is not a soulless machine, but direct contact with a human who knows medicine and pharmacy. If an urgent health risk signal appears, we act immediately. Our average reaction time to a critical report is 47 minutes. Without unnecessary paperwork and waiting for board decisions — we take responsibility on ourselves and report what is needed, where it is needed.

Local Experience at 24 Mickiewicza St

Our headquarters in Poznań is the place where we physically analyze every medical case. You can visit us every Thursday between 9:00 AM and 2:00 PM for a short technical consultation. We focus on facts. If your drug requires specific supervision or additional post-marketing studies, we will tell you straight. We don't beat around the bush, because in pharmacy precision and law count. Concrete deadlines are our sacred duty.

Heads-up: Every first Sunday of the month between 2:00 AM and 4:00 AM, we perform system maintenance for reporting, which is the only planned moment of interruption in database access.

Need Support in Supervision?

Instead of looking for general advice, talk to someone who has been buried in medical papers for 11 years. We can take over your PSUR reports within 3 business days of signing the contract.