Skills

Our team of experts have vast Pharmacovigilance (Drug safety / Medical Writing) experience in pre/post-marketing reports in the pharmaceutical industry as regulatory compliance and dale carnegie certified trainer.

We provide below services

Call center for Individual Case Study Reports (ICSR).

Individual Case Study Report (US/EMEA/EVHUMAN/Latam) pre/post-marketing reports and Submission activity.

Medical /scientific writing on different types of reports eg. PSUR, PADER, PAER, DSUR, BRA, RMP, signal detection etc.

Automization process to ease the pharmacovigilance/Drug safety activity as per company/regulatory requirement.

MedDRA coding.

Pharmacovigilance CAPA Management.

Medical recode summarization activity.

Refrences

• • Processing and verifying overall consistency of cases (ICSR), assessment of literature, solicited, Clinical trial and spontaneous serious and non-serious cases on different types of safety database.
  • Entrusted with the task of Coding of events and indications through MedDRA coder.
  • Exposure in Coding of drugs by CDD

Time and Spatial Flexiblity

Ready to travel anywhere in the world on subject to availability of Visa

Get In Touch