Sathya Chowdary Reddy

Hello, 

Myself Satyaveni Reddy. I have 1.6 years of experience  in Pharmacovigilance.  My skills are relevant to the job requirement. Please find the attached resume for more information. I look forward to hearing from you about my application. Thanking you!

Drug Safety Associate

Navitas Life Sciences

Data Entry Associate

Performed data entry of ICSRs following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.

Performed Data Entry activities on safety databases- Argus (8.4).

Completed safety data entry for other report types with duplicate search, event ranking and coding using MedDA, coding of diseases and medications using WHO Drug.

Expertise in post marketing studies, spontaneous, partner, regulatory authority, product quality complaints, device related issue, and clinical trial reports with high accuracy within specified timeline and as per SOPs and project requirements.

Evaluate causality, seriousness and listedness for all cases.

Quality Reviewer

As a quality reviewer performed quality review of adverse event reports from clinical study/trial, post marketing studies, spontaneous cases, partner cases, regulatory authority cases processed by other team members.

Identified significant missing information from reports and ensured its collection by sending follow up letters or queries where appropriate and ensured its closures.

Performed single case unblinding, duplicate mergers and deletions after quality review, reviewed protocol updates for accuracy and made dechallenge / rechallenge determinations.

Identified case corrections and created updates in the safety database following medical review.

Literature Validation

Perform initial evaluation of reported adverse events (serious and non-serious) from all sources (abstracts and full text articles etc.).

Assess and identify company suspects and events attributed to suspects.

Perform quality review for literature surveillance activities.

I had completed B.Pharmacy in Vijaya Institute of Pharmaceutical Science for Women with GPA of  8.3 CGPA