Safety Associate - Japanese Language

IQVIA; Hyderabad; In loco; INR 300.000 - 450.000; Tempo pieno

Descrizione del lavoro

IQVIA Hyderabad is seeking a Safety Data Associate to review, assess and process pharmacovigilance data per regulatory guidelines. The role involves coding AEs, writing narratives, literature activities, and ensuring high quality deliverables.

The candidate will work under the guidance of senior operations staff, participate in meetings, and may mentor new team members. A science/healthcare background with 1–1.5 years of relevant experience is preferred.

Competenze

• Bachelor’s degree in scientific or healthcare discipline with 1–1.5 years of relevant experience.
• Good knowledge of medical terminology.
• Working knowledge of applicable Safety Database.

Mansioni

• Review, assess and process Safety data and information per regulations and SOPs.
• Perform pharmacovigilance activities including collecting and tracking AE/endpoint information.
• Code adverse events and products, write Narratives and literature-related activities.
• Maintain quality and productivity standards and comply with project processes.
• Mentor new team members and participate in project team meetings.

Conoscenze

Communication

Medical terminology

Microsoft Office

Attention to detail

Multitasking

Team player

Shifts flexibility

Project coordination

Formazione

Bachelor’s Degree in science/healthcare

High School Diploma

Strumenti

Safety Database

Literature databases

Descrizione del lavoro

Job Description:

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 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.


• 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.


• 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.


• 100% compliance towards all people practices and processes


• Perform other duties as assigned.

Qualifications

• High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req


• An Individual with a minimum of a Bachelor’s Degree in scientific or healthcare discipline or allied life sciences graduation with 1-1.5 years of relevant experience. Req


• Good knowledge of medical terminology. Intermediate


• Working knowledge of applicable Safety Database. Beginner


• Knowledge of applicable global, regional, local clinical research regulatory requirements. Beginner


• Excellent attention to detail and accuracy. Beginner


• Good working knowledge of Microsoft Office and web-based applications. Beginner


• Strong organizational skills and time management skills. Beginner


• 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, manage competing priorities and deadlines. Beginner


• Ability to delegate to less experienced team members. Beginner


• Willingness and aptitude to learn new skills across Safety service lines. Beginner


• Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Beginner


• Ability to work as a Team Player, contribute and work towards achieving Team goals. Beginner


• Ensure quality of deliverables according to the agreed terms. Beginner


• Demonstration of IQVIA core values while doing daily tasks Beginner


• Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Beginner


• Regular sitting for extended periods of time. Beginner


• May require occasional travel. Beginner


• Flexibility to operate in shifts. Beginner

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Requirements: