* Following the GCP, ICH guidelines, and sponsor's specific SOPs in day-to-day activities andescalating any quality issues and non-compliance cases to respective people.* Preparing and assisting in updating study-specific documents (eg. Vendor Oversight Plan, MajorIssue List, Major Protocol Deviation List)* Supporting the global clinical trial team in order to fulfill project objectives and assisting in thecoordination of cross-functional teams* Facilitating effective… Show more * Following the GCP, ICH guidelines, and sponsor's specific SOPs in day-to-day activities andescalating any quality issues and non-compliance cases to respective people.* Preparing and assisting in updating study-specific documents (eg. Vendor Oversight Plan, MajorIssue List, Major Protocol Deviation List)* Supporting the global clinical trial team in order to fulfill project objectives and assisting in thecoordination of cross-functional teams* Facilitating effective communication within a study team through preparation and scheduling meetings, drafting meeting minutes, updating action and decision logs, FAQs, preparing Newsletters, etc.* Contributing to the development of best practices for study-specific processes and procedures* V-TMF management through timely filing of the documents, quality reviews of TMF content,ensuring TMF completeness* Maintaing the systems and tools to ensure completeness and accuracy of the data; managingaccesses for the team members (EDC, CTMS, IVRS, ERT)* Ensuring Inspection Readiness as per Project requirements* Assisting in Vendor Management (attending meetings, ensuring fulfillment of agreed projectstrategy objectives)* Assisting in Country and Site management (tracking regulatory submissions, ensuring compliance,and data completeness via metrics, reports sharing, and active follow-up on any discrepancies)* Providing an overview of data management metrics as requested (DE, missing pages, SDVprogress, support Query resolution)* Acting as part of SME team (Trials2You) in order to support the implementation of clinical trialsdecentralization initiative (HHC, Digital Health, eCOA, etc) Show less

• Processing Individual Safety Reports (ICSRs) in the electronic database in accordance with Standard Operating Procedures (SOP's), company policies, and as required by authorities or other stakeholders. • Reviewing source documents information to verify accurateness, completeness, or consistency and solving problems with data discrepancy in received reports •Working knowledge of MedDRA, WhoDrug coding principles, and ICH/GCP guidelines dedicated to the pharmacovigilance department.… Show more • Processing Individual Safety Reports (ICSRs) in the electronic database in accordance with Standard Operating Procedures (SOP's), company policies, and as required by authorities or other stakeholders. • Reviewing source documents information to verify accurateness, completeness, or consistency and solving problems with data discrepancy in received reports •Working knowledge of MedDRA, WhoDrug coding principles, and ICH/GCP guidelines dedicated to the pharmacovigilance department. •Ensuring incoming adverse events (SUSAR, SSAR, and non-serious) are processed properly within the training activities to provide the highest quality and accuracy. •Performing Quality Control activities on cases processed by other associates •Taking care of KPI requirements demanded by the client •Submitting safety reports to respective units •Performing all activities within the required time frames to ensure regulatory compliance •Prioritizing the workload according to requests from internal and external stakeholders. Show less