Pharmacovigilance & Medical Affairs

Pharmacovigilance & Medical Affairs

Pharmacovigilance & Medical Affairs

Integrated security monitoring and medical-scientific support

Safety management is a critical element throughout
clinical development. Our involvement in pharmacovigilance, medical affairs, and support for Independent Data Monitoring Committees (DSMB) ensures a continuous and rigorous assessment of the risk-benefit relationship, supporting clinical, ethical, and regulatory decisions based on scientific evidence.

Pharmacovigilance

We offer comprehensive pharmacovigilance services for clinical studies, ensuring the identification, evaluation, monitoring, and proper communication of adverse events, in compliance with local and international regulations.

Collection, screening, and medical assessment of adverse events (AE) and serious adverse events (SAE)

Collection, screening, and medical assessment of adverse events (AE) and serious adverse events (SAE)

Assessment of causality, severity, and outcomes of events

Assessment of causality, severity, and outcomes of events

Preparation and submission of safety notifications to regulatory authorities and ethics committees

Preparation and submission of safety notifications to regulatory authorities and ethics committees

Management of serious adverse events (SAE) and closing visits

Management of serious adverse events (SAE) and closing visits

Preparation of periodic safety reports (DSUR, SUSAR reports, line listings)

Preparation of periodic safety reports (DSUR, SUSAR reports, line listings)

Implementation and maintenance of risk management plans (RMP)

Implementation and maintenance of risk management plans (RMP)

Compliance with Good Pharmacovigilance Practices (GVP)

Compliance with Good Pharmacovigilance Practices (GVP)

Medical Affairs

Our Medical Affairs team acts as a link between science, clinical practice, and strategy, providing medical-scientific support for the safe and consistent conduct of clinical trials.

Scientific interface and medical support for clinical teams, monitoring, and researchers

Scientific interface and medical support for clinical teams, monitoring, and researchers

Review of protocols, amendments, and regulatory documents

Review of protocols, amendments, and regulatory documents

Assessment of safety and efficacy data throughout the study, with support for evidence-based clinical decision-making.

Assessment of safety and efficacy data throughout the study, with support for evidence-based clinical decision-making.

A Synvia

Why choose Synvia

More than two decades of experience across the entire drug research and registration chain.


We integrate clinical research, laboratory analyses, and technology to meet the demands of the pharmaceutical industry with quality and global compliance.

Contact

Talk to our experts

Discover how Synvia can support your studies, analyses, and projects.

Contact

Talk to our experts

Discover how Synvia can support your studies, analyses, and projects.