Safety Project Coordinator (Lifecycle Safety Project Management) - Home Based

Job Overview
Under general supervision, receive, track, distribute and file incoming safety and clinical event validation and adjudication (CEVA) data. Provide secretarial support for the department.

Essential Functions
• 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.
• Assist with system support tasks such as utilizing design specifications, AE form, and protocol, creating project specific entry specifications and annotated AE forms for safety database with direction from project lead and/or manager; creating project tracking spreadsheets and associated tracking entry specifications; assisting in database validation JOB through performance of user testing; performing ad hoc database searches for project team leads; assisting project lead in assessing database setup needs; and assisting with assuring systems issues are reported and resolved.
• Perform additional project-related and administrative tasks such as handling investigator mailings including creation of labels using investigator list, copying of documents, envelope stuffing, and tracking and filing of submitted materials; creating and maintain project files; working with project lead to develop project instructions; performing reconciliation between the safety and clinical databases; distributing AE listings to client and/or project team members; performing project start-up tasks; providing project metrics to management; and assisting with data entry, workflow and deadline quality measurements.
• Participate in continuous improvement of all departmental processes and procedures.

Qualifications
• Associate's Degree in a related field
•
• Basic knowledge of ICH and GCP
• Basic knowledge of medical terminology if processing
• Good understanding of Core Operating Procedures (COPs)
• Word processing and data entry skills
• Strong organizational skills and time management skills
• Flexibility and excellent verbal and written communication skills
• Ability to deal successfully with many internal clients competing for attention, services and resources
• Good attention to detail and accuracy
• Ability to establish and maintain effective working relationships with co-workers, managers and colleagues.
• Highly motivated and organised with a flexible attitude  Ability to follow instructions/guidelines, utilize initiative and work independently
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.