Prathamesh Kundale

Safety and Pv Coordinator @Syneos Health

Pune, IN

Monitors and routes incoming information to the appropriate projectRecords all ICSR documentation and tracks in accordance with Sponsor/customer specifications; distributes incoming mail and faxes.Redacts patient identifying information/images in accordance with data protection guidelines,ICH GCP and GVP.cordance -Enters data into the safety database in accordance with Sponsor/customer specific guidelines and Company standards.Ensures current conventions are followed when entering cases into the Safety database- Performs file creation, tracking, retention, and maintenance (paper and electronic)-Manages the translation process for any source documents requiring translation-Performs or assist with query follow up process as instructedAssists with submission processes as required.Assists with daily workflow reconciliation-Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (Wis), global drug/biologic/device regulations, GCPs, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process.

Maharashtra State Board of Secondary and Higher Secondary Education (MSBSHSE)

Science

Maharashtra State Board of Secondary and Higher Secondary Education (MSBSHSE)

Science

Shivaji University, Kolhapur

Bachelor of Pharmacy - BPharm