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Pv Associate - Japan

0-2 years
Not Disclosed
10 Nov. 20, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Company Overview

PrimeVigilance, a division of Ergomed PLC, is a leading pharmacovigilance service provider, specializing in regulatory affairs, medical information, quality assurance, and pharmacovigilance. Established in 2008, we have achieved consistent global growth, with employees based across Europe, North America, and Asia. We support pharmaceutical and biotechnology companies, offering expertise across all therapy areas, including medical devices. At PrimeVigilance, we prioritize staff development, well-being, and a healthy work-life balance, ensuring a thriving work environment that drives high-quality client services.

Job Summary

We are seeking a dedicated individual to join our team and contribute to the efficient management of Individual Case Safety Reports (ICSRs). This role involves collaborating with clients and internal teams, ensuring compliance with regulations, and supporting a variety of pharmacovigilance activities. The ideal candidate will be fluent in English and Japanese, with a keen interest in pharmacovigilance and a strong attention to detail.

Key Responsibilities

  • Manage and process Individual Case Safety Reports (ICSRs) from various sources, ensuring compliance with applicable regulations and client-specific requirements.
  • Provide support for SAE/SUSAR management, including unblinding, clinical trial reconciliation, and protocol reviews.
  • Handle product quality complaints in collaboration with the Quality Assurance team.
  • Perform follow-up activities on ICSR cases and support monthly reporting for clients.
  • Participate in various pharmacovigilance and safety activities as directed by senior team members.

Qualifications

  • Degree in Life Sciences or a related field.
  • Strong desire to pursue a career in pharmacovigilance.
  • Fluency in English and Japanese is essential.
  • Proficient in MS Office and general IT skills.
  • Excellent organizational and communication skills, with strong attention to detail.

Why Join PrimeVigilance?

At PrimeVigilance, we value diversity, equity, and inclusion, creating a supportive environment where all employees can thrive. We offer ample training and career development opportunities, a collaborative team culture, and the chance to work with colleagues worldwide. If you share our values of quality, integrity, drive, and collaboration, we invite you to apply and help us make a positive impact on patients' lives.

Join us on this exciting journey to improve global healthcare!