Safety writing / Pharmacovigilance

 

 

 

 

 • RMP - risk management plans (including epidemiology of indications and target populations)

 • PSUR / PBRER

 • DSUR

 • Addendum to Clinical Overview

 • Case Narratives

 • PSMF

 

 

 

 • (S)AE reporting, ICRSs, query management, case processing and assessment including MedDRA coding

 

 • Literature safety review for periodic safety reports  and for (S)AE reporting

 

 • Consultancy with regard to Good Pharmacovigilance Practices (GVP)

 

 

 

 

Indications:

 

Non-small cell lung cancer, asthma, chronic obstructive pulmonary disease, diabetes, haemophilia, pain and fever, hypothyroidism, alcohol withdrawal syndrome, agitation and insomnia, dietary supplements, thromboembolism prophylaxis, thrombolysis, common cold, secretolysis in bronchopulmonary diseases, oncology, oral contraception, depression

 

 Quality and Competence with Care

Impressum  - Links