Pharmacovigilance Analyst

6 - 10 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: You will be responsible for Pharmacovigilance data entry tasks, specifically catering to N1 Japanese bilingual requirements. With 6 to 8 years of relevant experience, your expertise in Pharmacovigilance data entry will be crucial for this position. You should be capable of understanding source documents, assessing safety information for ICSR cases, coding verbatim events using MedDRA dictionary, and determining the seriousness, listedness, and causal relationship of events. Additionally, you will be expected to interpret source documents from a medical perspective and provide narrative descriptions chronologically. Your role will also involve quality management tasks such as performing retrospective reviews, ensuring accuracy in coding, and summarizing review results. Furthermore, you will be responsible for managing timelines, tracking deliverables, and maintaining effective communication with clients and global team members. Key Responsibilities: - Expertise in Pharmacovigilance data entry - Understanding and interpreting source documents - Coding verbatim events using MedDRA dictionary - Assessing seriousness, listedness, and causal relationship of events - Describing narratives chronologically - Performing quality retrospective reviews - Reviewing accuracy of coding - Summarizing review results - Managing timelines for deliverables - Tracking deliverable status - Communicating effectively with clients and global team members - Writing in a logical and coherent manner - Reporting status appropriately Qualifications Required: - 6 to 8 years of relevant experience in Pharmacovigilance data entry - Expertise in interpreting source documents and safety information - Proficiency in coding using MedDRA dictionary - Strong communication and writing skills - Fluency in Japanese (N1 level) - Ability to manage timelines effectively - Experience in quality management and review processes Please note that the Hiring Process for this position will involve screening rounds with HR, as well as technical assessments in two rounds before the final HR round.,

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Phygital Insights

Technology, Marketing

San Francisco

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