Managing the in-scope drug safety activities for Client products including processing of Individual case safety reports and their medical review. Creation of periodic safety reports, management activities and reporting and publishing of safety documents in compliance with the patient safety regulations.
Role Description:
Worked in Covid-19 Vaccine project for AstraZeneca (Sapphire database). The purpose of this position was to provide effective service to client Pharma Company, to help them comply with Pharmacovigilance regulatory responsibility of Individual case safety reporting.
CERTIFICATIONS:
PROFILE
MASTER OF PHARMACY PROJECT DETAILS:
Formulation, Development and Evaluation of Fast Dissolving Tablet of Amisulpride using Cocrystallization technique.
Tools
Sapphire (database of case handling), AZ clinical Dictionary, Medical Dictionary for regulatory activities.
Computer skills
MS Office, MS Word, Power point, Excel, Internet Basics.
Technical skills
ICH-GCP guidelines (International Conference on HarmonizationGood Clinical Practice), PSUR, Clinical Research, Clinical Trial, MedDRA, Pharmacovigilance, Handling of Individual Case safety reporting (ICSRs), Narrative writing, GCP, Adverse drug reaction (ADR), Adverse event (AE), Analytical techniques (Physical, chemical methods, HPLC, HPTLC, TLC, Chromatography, etc.), GMP, Pharmaceuticals, Risk Management, Theoretical knowledge of Regulatory affairs, Quality Management, CAPA, MedDRA.
Managing the in-scope drug safety activities for Client products including processing of Individual case safety reports and their medical review. Creation of periodic safety reports, management activities and reporting and publishing of safety documents in compliance with the patient safety regulations.
Role Description:
Worked in Covid-19 Vaccine project for AstraZeneca (Sapphire database). The purpose of this position was to provide effective service to client Pharma Company, to help them comply with Pharmacovigilance regulatory responsibility of Individual case safety reporting.
CERTIFICATIONS:
PROFILE
MASTER OF PHARMACY PROJECT DETAILS:
Formulation, Development and Evaluation of Fast Dissolving Tablet of Amisulpride using Cocrystallization technique.
Tools
Sapphire (database of case handling), AZ clinical Dictionary, Medical Dictionary for regulatory activities.
Computer skills
MS Office, MS Word, Power point, Excel, Internet Basics.
Technical skills
ICH-GCP guidelines (International Conference on HarmonizationGood Clinical Practice), PSUR, Clinical Research, Clinical Trial, MedDRA, Pharmacovigilance, Handling of Individual Case safety reporting (ICSRs), Narrative writing, GCP, Adverse drug reaction (ADR), Adverse event (AE), Analytical techniques (Physical, chemical methods, HPLC, HPTLC, TLC, Chromatography, etc.), GMP, Pharmaceuticals, Risk Management, Theoretical knowledge of Regulatory affairs, Quality Management, CAPA, MedDRA.