Gowthami V Email & Phone Number

Bengaluru, Karnataka, India

Clinical Research Associate

❖ Awarded with Contextual Master Award❖ On Spot Awardee for the filing of the Process Improvement ❖ Assisted in the training team of around 450-500 on-boarding associates.❖ Data entry of post-marketed serious and / or non- serious Individual Case Safety Reports (ICSR) ensuring compliance and Client Standard Operating Procedures (SOPs) and work instructions in Veeva Vault Safety Database as the pioneer batch.❖ Had initiated the Process Improvement and was able to reduce the efforts by 30% for the team. ❖ Maintain knowledge and understanding of SOPs

Enter preliminary and follow-up information from source documents into the Sapphire Database.Data entry of post-marketed serious and / or non- serious Individual Case Safety Reports (ICSR) ensuring compliance and Client Standard Operating Procedures (SOPs) and work instructions.Coding of suspect drugs, concomitant drugs, treatment drugs and previously prescribed drug using Company Drug Dictionary.Verifying the data entered in the cases for accuracy, consistency, and compliance with process requirement.Use MedDRA to code adverse events, indications of suspect, and concomitant medications, medical history and laboratory investigations.Maintain knowledge and understanding of SOPs.

Karnataka, India

A full-pledged training of 150hours in the pharmaceutical company as prescribed by the Rajiv Gandhi University of health sciences.Hands-on experience of real-time operational procedures involved in the production of the Pharmaceuticals and their quality testing procedures.Understanding structuring of the BMR and MFR.Implementation of the SOP.Documentation as per the Regulatory requirements.Quality check procedures