Drug Safety Operations Coordinator/specialist

7 months ago

Kuala Lumpur, Malaysia Novasyte Full time

As our business grows, we are looking to further strengthen our Medical Information & Pharmacovigilance team by hiring Drug Safety Operations Coordinator/Specialist in IQVIA Malaysia.

As part of the Safety Operations team, you will provide data gathering, entry, and reporting services on behalf of contracted customers, including both clinical trial and marketed product safety activities. Also, you triage, track, and process safety data; assesses safety data for report-ability to the client safety department or relevant regulatory bodies; maintains communication with investigative sites or marketed product reporters to obtain accurate data regarding safety events; and contributes to lifecycle safety deliverables.

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 endpoint 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.
- 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.
- 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.
- 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 manager
- Creating project tracking spreadsheets and associated tracking entry specifications
- Assisting in database validation through performance of user testing
- Performing ad-hoc database searches for operations team leads
- Assisting operations team member in assessing database setup needs
- Assist with project phone/fax line set-up as required
- Escalating 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.
- Provide training/mentoring to new/less experienced staff.
- 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.

Key Requirements:

- Diploma or Bachelor’s Degree in Life Sciences or healthcare discipline or allied health sciences.
- Work experience in healthcare settings will have an advantage.
- Proficiency in Chinese Language will be beneficial as the role will support and liaise with Chinese-speaking market.
- Good knowledge of medical terminology.
- Strong organizational skills and time management skills.
- Strong verbal/written communication skills.
- Self-motivated and flexible. Excellent attention to detail and accuracy.
- Ability to follow instructions/guidelines, utilize initiative and work independently.
- Proven ability to multi-task, manage competing priorities and deadlines.
- Willingness and aptitude to learn new skills across all Lifecycle Safety service lines.
- Flexibility to operate in shifts.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest

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