Roles and responsibilities:As a Senior Drug Safety Associates: Review and evaluate AE case information to determine required action based on and following internal policies and procedures.Process current incoming cases in order to meet timelines.Provide guidance for Data entry & Quality teams.Following up with sites regarding outstanding queries.Follow-up on reconciliation discrepancies.Follow departmental AE workflow procedures.Train and mentor new team members as per requirements of the project.Delegate tasks and responsibilities to appropriate personnel.Identify and resolve issues and conflicts within the project team.Act as guide, coach and counselor for the team.Closure and deletion of cases.Oversee, mentor and guide the activities of the Drug Safety Associates.High level of proficiency at all workflow tasks.Perform any other drug safety related activities as assigned.Experience with relevant safety databases and software applications.Closure and deletion of cases.Mentor and guide the activities of the Dug Safety Associate.Perform any other drug safety related activities as assigned.Review data entered in safety database for completeness and accuracy.Provide quality feedback to team resources.Track and maintain quality metrics.Responsible for data entry of Individual case safety reports into the safety database.Review and evaluate AE case information to determine required action based on and following internal policies and procedures.Process all incoming cases in order to meet timelines.Full data entry including medical coding and safety narrative.Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD).Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.

Roles and responsibilities:Perform QC review activities of the departmental operations to ensure compliance to SOPs, study protocol, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), quality standards and regulatory requirements.Review of method validation and study date for accuracy, Integrity, compliance and Completeness.Review of method validation and study report to ensure that they accurately reflect the raw data and study conduct.Review Pharmacokinetic and Statistical data for compliance to SOPs, study protocol and regulatory requirements.Ensure corrective actions to Quality Assurance audit reports and provide response for the same.Prepare, review and revise departmental SOPs in accordance to regulatory requirements; GSOP and GQs.To ensure proper receipt and storage of Drug Products at central pharmacy from various regions of the company.To compile all relevant documentation for Drug Products as per GLP requirements.To review supporting documents and shipment records received with Drug Products for accuracy and completeness.To ensure complete traceability of the drug products including temperature records during transit and storage. Implement the usage of data loggers for shipment of drug products by all concerned groups.To plan and manage shipments / transfer of Investigational Medicinal Products under required temperature conditions to CPUs / CROs for conduct of BA/BE studies.To provide all required details of the investigational products and handle investigational medicinal products related queries received from CPUs, CROs, QC and QA.To provide drug products to Formulation department/Plants for In-vitro evaluation.Coordination, review and reconciliation of each and every unit of IMP recalled.To ensure proper controlled conditions are maintained in the Pharmacy. Ensure printing and review of temperature and humidity records from Eurotherm Monitoring System as per SOP.

Ensuring quality of process by reviewing all study related documents like-Protocol, Clinical study report, Trail master file, Study Synopsis, Study close out report, Case record form, Screening examination record, Informed Consent Document, Interim Updates.Monitoring SAE and AE management and reporting to all applicable bodies (Regulatory, Ethics Committee, and Sponsor as per their timelines).Ensuring compliance of Standard operating procedure, Regulatory guidelines, and all applicable laws.Participated in external audits by sponsors and other oversight entities such as FDA?s.Overall audit of all the pre study, during study and after study documents in clinic operations.Responsible for preparation for relevant standard operating procedures as per the current technicalities with respect to ICH GCP guidelines and other regulatory requirements.Coordination with independent ethics committee and institutional review board for approval of projects.Responsible for preparation for Protocol and its attachments( CRF,ICD) as per the current technicalities with respect to ICH GCP guidelines and other regulatory requirements.Training of relevant SOPs to all staff of the department.To assist the project coordinator for smooth conduct of study.Handling 20 staff (Project coordinator, Pharmacist & Phlebotomist).Assist Principal Investigator / Co- Investigator / Medical Officer in preparation of protocols as per current technicalities with respect to ICH GCP guidelines and other regulatory requirements in consultation of principal investigators.Preparation of case report forms/study source documents and informed consent documents in English in consultation of Principal investigator / Co ? Investigator.Ensuring translation and validation of translation into vernacular language of English informed consent documents.Preparation and maintain Trail master file of various clinical studies.Preparation of clinical studies reports as per different regulatory requirements.

Roles and responsibilities:Migrate data from source document to ARGUS Pharmacovigilance tool.Case processing/assessment of different types of reports/cases in Argus database.Coding of Events through MedDRA.Coding of drugs using company drug dictionary (CDD) and WHO drug dictionary (WHO DD).Prioritization of cases as per timelines and seriousness criteria and proofreading of cases for accuracy before routing to the next workflow step within timelines.Knowledge of labeling causality assessment.Knowledge of narrative writing, documentation, and contact log Perform follow up activities with HCP and Non-HCP.Team meeting for query resolution/updates and action plan to maintain the quality and productivity of the team.

Roles and responsibilities:Review of all data generated during conduct of Clinical Studies.Review 100% of Clinical raw data for completeness, accuracy, and for compliance with Study Protocol, ICH-GCP, SOPs and applicable Regulatory Guidelines.Identify accountability of each personnel in project and scope of improvements needed in consultation with VP Operation.Keep track of timelines defined from study initiation to archival.Responsible for procurement and handling of investigational products of Clinical Trial along with Principal Investigator/ VP Operations.Responsible for Investigational Product trial related documentation and performing trial-related activities with other study personnel.Receipt of Investigational Products and its documentation in consultation with Principal Investigator.Storage, Inventory, Accountability, Retention and Archiving of Investigational Products as per Regulatory requirements.Destruction or shifting of unused or expired Investigational Products.Responsible for handling and maintenance of Pharmacy.