Be a part of a global team to help ensure the safety profile of a COVID-19 vaccine with opportunities to improve worldwide public health.
Use your scientific and foreign language expertise to join the world’s leading comprehensive pharmaceutical safety services organization on a fast-growing team performing medical information call centre services.
Manage the administrative support across all Lifecycle Safety service lines to the SO and LSM functions as appropriate. Provide support to administrative team members.
The Role :
Review, assess and process safety data and information, across service lines, received from various sources and distribute reports / data onwards to both internal and external third parties, following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.
Key responsibilities :
Assist in processing of Lifecycle Safety data by collecting and tracking incoming Adverse Events(AE) / endpoint information, determining initial / update status of incoming events, tracking timelines for completion of event processing, distributing event information to appropriate project personnel in the workflow for continued processing, review and preparation of end point documentation, transfer of events to client and other parties as identified by operations lead, obtaining confirmation of report receipt and track submission and assuming workflow responsibilities for various projects.
May assist with project workflow including database entry, quality control activities, and generation of Lifecycle Safety data reports, preparation of Lifecycle Safety submission dossiers, assisting with deadline quality measurements, as directed by operations team member or manager.
Assist with administrative team support e.g. project start-up tasks, creation and maintenance of project files, systems access requests periodic distribution of AE listings and shipping of information supplies to sites as directed by senior operations team member.
May coordinate, schedule and submit safety reports to regulatory authorities, marketing authorization holders, investigators, customers and operations team in accordance with deadlines perform project administrative tasks such as creation of labels using investigator list, maintenance of personal safety files for mail merges and regulatory documents, copying of documents, envelope stuffing, tracking and filing of submission dossiers, and distributing listings to client and / or operations team members.
Creating, maintain and track case folders, filing, retrieving and distribution of case folders to operations team members, assisting in maintenance of document control storage and relevant applications / systems as directed.
Archiving case folders and project files after event closure, coordination of transfer of archived material to company / customer archive storage facilities after study closure, assisting in creation of records management processes and procedures, providing key input to operations team on acquisition and / or upgrade of records management application / systems and serving as liaison between Lifecycle Safety department and records management department.
May assist with system support tasks such as utilizing design specifications, study form, and protocol to create project specific entry specifications and annotated project forms for database under guidance from operations lead and / or managercreating project tracking spreadsheets and associated tracking entry specificationsassisting in database validation through performance of user testingperforming ad hoc database searches for operations team leadsassisting operations team member in assessing database setup needsassist with project phone / fax line set-up as requiredescalating any system / equipment problem.
Oversee and co-ordinate administrative support by coordinating team / department / customer / project oversight group meetings, coordinating stationery orders, dispatching documents via courier services, reserving meeting rooms and IT equipment and providing administrative support where required.
Identify and record process or quality problems and bring them to the attention of a senior team member.
Participate in continuous improvement of all departmental processes and procedures by identifying and implementing efficiencies in workflow and / or case processing.
Co-ordinate, oversee and delegate resource tasks to administrative team members as appropriate and monitor the intake of cases and archiving process when multiple coordinators are involved.
Involvement and contribution in local / global department committees.
Perform other duties as assigned.
Minimum Required Education and Experience :
Must be Fluent in English plus one other language from French or Spanish or Italian or Dutch or German or Baltic and Nordic languages.
2 years’ relevant work experience.
Equivalent combination of education, training and experience.
Skills and Abilities :
Excellent attention to detail and accuracy.
Good knowledge of medical terminology.
Working knowledge of applicable Safety Database.
Self-motivated and flexible.
Ability to follow instructions / guidelines, utilize initiative and work independently.