Expertiise Knowledge in Clinical Data Management Processes (Study startup, Study conduct, Study close-out)o Data Management Plano CRF designingo Database specificationo Edit check Specification/Data validations Specificationo UATo Discrepancy Managemento Medical Coding- MedDRA and WHODDo SAE reconciliationo Lab reconciliationo Protocol Deviationso Freeze and LockPreparation of Schedule of assessment (Time and Events) based on the protocol requirements.Expertise Knowledge In Pharmacovigilance :• ADR, Serious Adverse Reaction, SUSAR, SAE, MedDRA, Risk Management, ADR Monitoring, Narrative Reports.• ICSR, SAE Reporting timelines, ICH- E2a, E2b, E2c guidelines• PSUR, DSUR, Volume 9A, CIOMS• Causality Assessment, Signal, Frequency of ADR, De-challenge, Re-challenge• Good Knowledge on Oracle Argus Safety 7.0.2 Database - Data Entry, Case Processing MedDRA coding, SAE narrative writing.3. Certification in Regulatory Affairs:• Knowledge of Global Regulatory Authorities for pharma and healthcare industries• Knowledge of Drug Development Process, Clinical Trials and related norms and regulations• Knowledge of GMP and other good practices• Knowledge of Documentation of drug trials and regulatory filings in US, Europe, UK, India, Japan, Canada, Australia, South Africa, etc.• Knowledge of Quality Assurance and Drug Regulations, ICH and WHO guidelines• Knowledge of CTD Submission and DMF Filing