05/09/2018 updated

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Argus Safety, Pharmacovigilance processes, Clinical Research, Trainings

Chandigarh, India
India
Chandigarh, India
India

InnovationTeachingMedical ResearchClinical Data ManagementClinical ResearchCommunicationPharmacovigilanceFunctional TrainingLeadershipGood Clinical Practices (GCP)Project ManagementMedDRAOperations ManagementOracle ApplicationsSAS (Software)Technical CommunicationPresentationsIch GuidelinesTeam-workingArgusProfessional DevelopmentSafety PrinciplesPeriodic Safety Update ReportUser Administration
•In-depth experience in techno-functional training on Oracle Argus Safety 7.0 including:
o Argus activities
o User management
o Case processing including duplicate check, case book-in, follow up, coding, medical review, reports generating (Expedited, Aggregated, PSUR) and dashboard reports

•Proficiency in WHO-DD and MedDRA Dictionary.

•Knowledgeable in various regulatory guidelines like ICH guidelines, Good Clinical Practices, Good Documentation Practices and Volume 9A etc

•Innovative, Strong presenter with proven ability to design and deliver training to a variety of individuals on topics ranging from Pharmacovigilance, Clinical Research, SAS, Clinical Data Management to Professional Development like Leadership, Team Work, Communication, Integrity, Performance etc.

•Experienced in creating classroom and web-based training and instructional materials, teaching aids, and devices, as well as technical manuals and user guides.

•Superior communication, diagnostic, technical, and presentation skills

•Strong Project management and Operations management skills

•Expert in trainings at all levels in an Organization and Institutes

Languages

EnglishNative speaker

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