Safety Associate
- IQVIA
- 1 - 3 years
- Kolkata
- 9 months ago
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Job Description
Project Role: Safety Associate
Work Experience: 1 to 3 years
Work location: Kolkata/Bangalore
Work Mode: Office based.
Must Have Skills: ICSR case processing, argus database , Drug safety
Educational Qualification: B. Pharm/M. Pharm/PharmD
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 Bachelors 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
Job Classification
Industry: IT Services & ConsultingFunctional Area / Department: Healthcare & Life Sciences, Role Category: Healthcare & Life Sciences - OtherRole: Healthcare & Life Sciences - OtherEmployement Type: Full timeContact Details:
Company: IQVIALocation(s): Kolkata
Keyskills: MedDRA Drug Safety Case Processing Argus Safety Arisg Pharmacovigilance ICSR Argus Adverse Events Oracle Argus
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IQVIA
IQVIA Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources.
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