Looking for freshers who has completed their graduation B.Pharma/M.Pharma/ BDS/ M.Sc/B.Tech.
Provide intake and tracking of initial safety and clinical event validation and adjudication (CEVA) data. Transfer incoming safety/CEVA data to project team. Identify any problems with incoming faxes and bring them to the attention of the senior team member.
Distribute safety data to marketing authorization holders, customers, regulators and investigators.
Specific project responsibilities include set-up and/or maintenance of safety/CEVA files for reported events; archiving of files when closed; coordination of transfer of archived material to company/customer archive storage facilities; preparation and assistance in setting-up and updating project files; maintenance of personal safety files for mail merges and regulatory documents; where required, data entry of events into tracking database and assistance of transfer of events to customers.
Provide administrative support for the department by coordinating team/department/customer meetings, coordinating stationery orders, dispatching data via courier services, reserving meeting rooms and IT equipment; and providing secretarial support as required.
Generate and distribute alert letters.
Identify and record quality problems and bring them to the attention of a senior team member.
Provide training/mentoring new/less experienced staff.
Assist project lead and CEVA management with specific aspects of CEVA processes.
Set up and maintain Serious Adverse Event (SAE) files for reported events; organize and send files for archive when events are closed.
Coordinate, schedule and submit reports to regulatory authorities in accordance with deadlines.
Coordinate distribution of safety letters to study investigators and Clinical Research Associates.
Assist in processing incoming and outgoing Adverse Event (AE) reports by collecting and tracking incoming AE reports sent via fax, email, eCRF, etc; determining initial/update status of incoming events; tracking timelines for completion of AE processing; performing data entry into safety database; routing report information to appropriate PhV project personnel in the workflow for continued processing; performing quality control activities as directed by project lead or manager; generating established safety data reports; submitting AE reports to client and other project team members identified by project lead; obtaining confirmation of report receipt and track submission; and assuming workflow responsibilities for local and global projects.
Perform records management tasks such as creating and tracking case folders for AE reports; filing, retrieving and delivering case folders; assisting in maintenance of document control room and relevant applications/systems as directed by manager; archiving case folders and project files; assisting in creation of PhV records management processes and procedures; providing key input to management on acquisition and/or upgrade of records management application/systems; and serving as liaison between Pharmacovigilance department and records management department.
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