Safety Associate

0-1 years

Not Disclosed

Pune

10 Dec. 5, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Safety Associate

Location: Flexible

About IQVIA
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 IQVIA Careers.

Job Overview:
As a Safety Associate, you will be an essential part of the pharmacovigilance team, responsible for ensuring the accurate and efficient processing of safety data. This includes handling adverse event cases, contributing to safety compliance, and maintaining the integrity of safety documentation in alignment with global and local regulations.

Key Responsibilities:

Case Processing:
- Review, process, and document adverse event cases in Japanese language.
- Perform data entry of safety information into relevant safety databases.
- Translate Japanese safety reports to English and ensure accuracy in reporting.
Regulatory Compliance:
- Ensure all safety data is processed in accordance with IQVIA Standard Operating Procedures (SOPs), regulatory guidelines, and global/local requirements.
- Monitor and adhere to timelines for case processing and reporting.
Quality Assurance:
- Conduct quality checks on safety data and reports to ensure accuracy and completeness.
- Identify and escalate potential safety concerns or data inconsistencies.
Collaboration:
- Work closely with cross-functional teams, including global safety teams and Japanese-speaking colleagues, to support case management and compliance activities.
- Provide guidance and support to team members regarding Japanese language cases.
Documentation and Reporting:
- Maintain accurate records of all safety-related documentation.
- Assist in preparing periodic safety update reports (PSURs) and other required regulatory submissions.
Continuous Improvement:
- Actively participate in training sessions to enhance knowledge of safety processes and regulations.
- Contribute to process optimization and identify areas for operational improvement.

Qualifications:

Bachelor's degree in life sciences, pharmacy, nursing, or related field.
Fluency in both Japanese and English (written and spoken) is essential.
Experience in pharmacovigilance or safety case processing preferred.
Strong understanding of pharmacovigilance guidelines, including ICH, GVP, and other regulatory requirements.
Attention to detail, excellent organizational skills, and the ability to meet deadlines.
Proficiency in safety databases and tools is a plus.

Why IQVIA?
At IQVIA, we value diversity, innovation, and a commitment to improving healthcare outcomes. We offer competitive salaries, comprehensive benefits, and opportunities for career growth within a collaborative and inclusive work environment.

If you’re passionate about advancing healthcare and making a difference in patients’ lives, join us at IQVIA.

This job description is tailored to highlight the specifics of the "Safety Associate" role, including the unique requirement for Japanese case processing. Let me know if you'd like further adjustments!

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Safety Associate

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