DOE, Pre- formulation , Formulation, Method Development, Validation

SKILLS: • Strong and thorough understanding of drug development process and clinical development plans• Excellent knowledge of key system organ classes such as Endocrine disorders, Cardiovascular disorders, Infection and infestations, Nervous system disorders, Oncology and Respiratory disorders.• Comprehensive knowledge of Clinical trials (Phase I – IV).• Concrete knowledge of US-FDA regulations, compliance with timelines, case report submission, adverse event reporting… Show more SKILLS: • Strong and thorough understanding of drug development process and clinical development plans• Excellent knowledge of key system organ classes such as Endocrine disorders, Cardiovascular disorders, Infection and infestations, Nervous system disorders, Oncology and Respiratory disorders.• Comprehensive knowledge of Clinical trials (Phase I – IV).• Concrete knowledge of US-FDA regulations, compliance with timelines, case report submission, adverse event reporting, review source documents and • Good understanding of IND safety reports, 21 CFR part 11, GCP, GLP, ICH and IRB guidelines• Knowledge of MedWatch and CIOMS reports.• Experience with database management and SAE/AE coding with MedDRA and drug coding with WHODD, CDD• Knowledge of PSURs and PADERs• Proven ability to identify Adverse Events and Product Complaints.• Narrative writing, data entry and tracking. • Participated in the triage process of incoming adverse event cases to ensure timely and effective assessment and evaluation of cases. • Assessed the seriousness of the cases and reviewed the package inserts for expectedness.• Assessed causality and coordinated with the medical team for clarifications.• Performed data entry into safety database and code adverse events using MedDRA and product information using company product dictionaries.• Reviewed and processed initial and follow-up information for both serious and non-serious cases by producing auto and manual narratives using the appropriate narrative template and coding adverse events, suspect products and concomitant products using MedDRA and other company dictionaries within defined reporting timelines.• Manually generated MedWatch and CIOMS reports as applicable.• Performed quality checks to ensure accurate case information is entered into safety database.• Did data reconciliation between safety and clinical databases.• Ensured that expedited reports are processed and sent to regulatory affairs department. Show less

• Made the first diagnoses and immediate treatment plans for in-patients and recorded case history of each patient; Participated in making long-term treatments for in-patients • Follow-up with indoor patients for any improvements and/or side-effects of medicines• Maintained case files and binders• Liaise with the supervisor for patient healthcare issues or any medication side-effects• Worked in different therapeutic areas like cardiovascular, Neurology, Metabolic, Oncology… Show more • Made the first diagnoses and immediate treatment plans for in-patients and recorded case history of each patient; Participated in making long-term treatments for in-patients • Follow-up with indoor patients for any improvements and/or side-effects of medicines• Maintained case files and binders• Liaise with the supervisor for patient healthcare issues or any medication side-effects• Worked in different therapeutic areas like cardiovascular, Neurology, Metabolic, Oncology, Nephrology, Pulmonology, etc. • Handling of emergency cases like Trauma cases, Myocardial Infarction cases, Stroke cases, DKA cases, etc. Show less