Durgaprasad .P Email and Phone Number

Case correction, ICSRs case processing.

Information Process Enabler, Expert in Medra coding

Experienced in performing Case Triaging to ensure expedited cases are processed within defined timelines of Regulatory authority & Business partnersPreparation of PSURs. Knowledge of MedDRA coding. Case narrative writing. GPvP on ICH / WHO / MHRA/ USFDA guidelines. ARISg Data base. Argus Data base ICSRs review and reporting.

Literature Search And ICSRs processing.

• Ensuring that a company's products comply with the regulations of the MHRA;• Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to;• Collecting, collating and evaluating scientific data that has been researched by colleagues;• Preparing submissions of licence variations and renewals to strict deadlines;• Writing clear, accessible product labels and patient information leaflets;• Planning and… Show more • Ensuring that a company's products comply with the regulations of the MHRA;• Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to;• Collecting, collating and evaluating scientific data that has been researched by colleagues;• Preparing submissions of licence variations and renewals to strict deadlines;• Writing clear, accessible product labels and patient information leaflets;• Planning and developing product trials and interpreting trial data;• Advising scientists and manufacturers on regulatory requirements;• Providing strategic advice throughout the development of a new product;• Project managing teams of colleagues involved with the development of new products;• Reviewing company practices and providing advice on changes to systems;• Liaising with, and making presentations to, regulatory authorities;• Specifying storage, labeling and packaging requirements. Show less

Professional Experience in Maintenance of Pharmacy records in Hospital. Dispensing of drugs to inpatients and outpatients, explaining regards to usage of prescribed drugs.• Ward round participation with physicians.• Providing Drug Information to the Health care professionals, patients.• Monitoring and reporting of Adverse Drug Reactions, Incompatibility Drug Reactions.• Providing Information to the Health care professionals.• Patient counselling and… Show more Professional Experience in Maintenance of Pharmacy records in Hospital. Dispensing of drugs to inpatients and outpatients, explaining regards to usage of prescribed drugs.• Ward round participation with physicians.• Providing Drug Information to the Health care professionals, patients.• Monitoring and reporting of Adverse Drug Reactions, Incompatibility Drug Reactions.• Providing Information to the Health care professionals.• Patient counselling and education.• Preparation of Data collection Form for the Research studies. Show less