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Job Location | Bangalore |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | R&D / Product Design |
EmploymentType | Full-time |
Advanced PG Diploma in Clinical Research & Pharmacovigilance Yogam Career Program Module for Clinical Research & Pharmacovigilance: General Overview of Clinical Research & Pharmacovigilance. Details about Clinical Research. Drug development process and requirement related to pharmaceutical industries Definitions of PV, CR, CDM, ADR, AE, SAE. Schedule y Regulatory guidelines & Rules & regulatory laws in PV Causality assessment & Methods Expedited Reporting & timeline ADR reporting forms Diag. & Mang. of Adverse drug Reactions. 21-CFR ADR ICH-GCP Adverse Event Signal Detection PV-Lifecycle PSUR SAE SAE timelines in PV Classification of ADR Aggregate reports MedDra & Medical dictionary Risk management plan SUSAR, DSUR, PBRER, ICSR Introduction to PV software in Detail Introduction of CDM/SAS/Clinical SAS R3 guidlines/ new uodated version Interview Questions Interview Assessments, Education:UG -BDS - Dentistry, B.Pharma - Pharmacy, B.Sc - Any Specialization, Bio-Chemistry, Biology, Microbiology, Nursing, Zoology, MBBS - Medicine, BVSC - Veterinary Science, BAMS - Any Specialization, Ayurveda, Other, BHMS - Any Specialization, Homeopathy, Other, B.U.M.S - Any Specialization, Unani Medicine, OtherPG - M.Pharma - Pharmacy, MS/M.Sc(Science) - Any Specialization, Bio-Chemistry, Biology, Biotechnology, Microbiology, Nursing, Zoology, Medical-MS/MD - Any Specialization, Neuro Surgery, MVSC - Veterinary Science, MDS - Any SpecializationDoctorate - Ph.D - Bio-Chemistry/Bio-Technology, Biomedical, Biotechnology, Genetics, Medicine, Microbiology, Nursing, Pediatrics, Pharmacy
Keyskills :
risk managementdrug development clinical researchposition management regulatory guidelinessignal detection