Pharmacovigilance (drug safety) services and Sermon CRO

Pharmaco

Within the range of services Sermon CRO offers, we also introduced pharmacovigilance services in clinical trials and for post-marketed products, specifically in:

  • communication of safety information,
  • assistance with pharamcovigilance processes,
  • support in preparation of SOPs.

Our Pharmacovigilance Officer will provide support in reporting Suspected Unexpected Serious Adverse Reactions - SUSARs to Health Authorities, tracking Individual Case Safety Reports - ICSRs, etc.

Our QPPV - Qualified Person responsible for Pharmacovigilance will provide support in establishing and maintaining Market Authorization Holder's (MAH) Pharmacovigilance system, overseeing the safety profiles of the company's marketed products and any emerging safety concerns, acting as a single point of contact for the regulatory Authorities on a 24-hour basis.