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.
Application Process: You will be required to complete a mandatory video assessment (HireVue) if you are shortlisted by Talent Acquisition team. You will receive an email notification about it, which will not take you more than 20 minutes to complete, and the deadline for submission is 96 hours after receiving the email.
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.
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 like 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
Bachelor's Degree in Pharmacy.
Must be proficient in Mandarin.
Must be base in Kuala Lumpur (hybrid work model).
At least 1-2 years of relevant Medical Information experience in the field.
Good knowledge of medical terminology.
Working knowledge of applicable Safety Database and any other internal/Client applications.
Knowledge of applicable global, regional, local clinical research regulatory requirements.
Good working knowledge of Microsoft Office and web-based applications.
Strong organizational skills and time management skills.
Strong verbal/written communication skills.
Ability to follow instructions/guidelines, utilize initiative and work independently.
Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands.
Ability to be flexible and receptive to changing process demands.
Willingness and aptitude to learn new skills across Safety service lines.
Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients.
Ability to work as a Team Player, contribute and work towards achieving Team goals.
Ensure quality of deliverables according to the agreed terms.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Flexibility to operate in shifts.
How to Apply: Interested candidates are invited to submit their resume and cover letter through this portal and please include "Medical Information Specialist Application" in the subject line.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Medical Information Specialist