日语药物警戒专员Operation Specialist1

Job Overview
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 Standard
Operating Procedures (SOPs) and internal guidelines under guidance and support
of senior operation team members.
Essential Functions
● To Prioritize and complete the assigned trainings on time.
● Process Safety data according to applicable regulations, guidelines,
Standard Operating procedures (SOPs) and project requirements.
● To perform Pharmacovigilance activities per project requirement including
but not limited to, collecting and tracking incoming - Adverse
Events(AE)/endpoint information
● determining initial/update status of incoming events
● database entry
● coding AE and Products, writing narratives, Literature related activities as
per internal/ project timelines.
● Ensure to meet quality standards per project requirements.
● Ensure to meet productivity and delivery standards per project requirements.
● To ensure compliance to all project related processes and activities.
● Read and acknowledge all necessary IQVIA standard operating procedures
(SOPs) and customer SOPs as required. Ensure all required training is executed
in a timely fashion and documented. Work towards ensuring your individual
training plan and training transcript are reconcilable.
● Creating, maintaining and tracking cases as applicable to the project plan.
● Identify quality problems, if any, and bring them to the attention of a
senior team member.
● To demonstrate problem solving capabilities.
● Liaise with different functional team members, e.g. project management,
clinical, data management
● health care professionals e.g. investigators, medical monitors, site
coordinators and designees to address project related issues.
● May liaise with client in relation to details on day to day case processing
activities.
● To mentor new teams members, if assigned by the Manager.
● Attend project team meetings and provide feedback to operations manager on
any challenges/issues or successes.
● Perform other duties as assigned.
● Lead/ Support department Initiatives
● 100% compliance towards all people practices and processes
● In addition to the above mentioned responsibilities, depending on the
project requirement, the team member may perform medical review of non-serious
adverse events (AEs) and non-serious adverse drug reactions (ADRs) which
includes reviewal of AE coding, past medical history, concomitant medications,
expectedness/ listedness, causality assessment and other medical information
and ensure completeness and accuracy of data according to applicable
regulations and guidelines, SOPs, project-specific guidelines, and medical
evaluation guidelines and communicate with the team leads for any correction
required in the case and maintain appropriate documentation for all
communications.
Qualifications
● High School Diploma or equivalent Scientific or healthcare discipline or
allied life sciences Req
● Bachelor's degree in life sciences or related field and up to 3 years of
relevant experience, inclusive of up to 1 year of Pharmacovigilance experience.
Req
● or equivalent combination of education, training and experience. Pref
● Good knowledge of medical terminology. Intermediate
● Working knowledge of applicable Safety Database and any other
internal/Client applications. Intermediate
● Knowledge of applicable global, regional, local clinical research regulatory
requirements. Intermediate
● Excellent attention to detail and accuracy. Intermediate
● maintain high quality standards. Intermediate
● Good working knowledge of Microsoft Office and web-based applications.
Intermediate
● Strong organizational skills and time management skills. Intermediate
● Strong verbal/written communication skills. Intermediate
● Self-motivated and flexible. Intermediate
● Ability to follow instructions/guidelines, utilize initiative and work
independently. Intermediate
● Ability to multi-task, meet strict deadlines, manage competing priorities
and changing demands. Intermediate
● Ability to delegate to less experienced team members. Intermediate
● Ability to be flexible and receptive to changing process demands.
Intermediate
● Willingness and aptitude to learn new skills across Safety service lines.
Intermediate
● Ability to establish and maintain effective communication and working
relationships with coworkers, managers and clients. Intermediate
● Ability to work as a Team Player, contribute and work towards achieving Team
goals. Intermediate
● Ensure quality of deliverables according to the agreed terms. Intermediate
● Demonstration of IQVIA core values while doing daily tasks Advanced
● Extensive use of telephone and face-to-face communication requiring accurate
perception of speech. Intermediate
● Regular sitting for extended periods of time. Intermediate
● May require occasional travel. Intermediate
● Flexibility to operate in shifts. Intermediate