Safety Associate Trainee - Kolkata, West Bengal, India - Novasyte

Novasyte

Verified Company

Kolkata, West Bengal, India

3 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

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:

Graduates in Bpharm/ Mpharm/ PharmD (Freshers only).
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
Strong organizational skills and time management skills. Beginner
Strong verbal/written communication skills. Intermediate
Selfmotivated and flexible. Intermediate
Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate
Ability to multitask, 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 facetoface 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 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 impact possible - to help our customers create a healthier world.

Learn more at