Senior GSPV Associate/シニアGSPVアソシエイト
給与 ¥6000000 - ¥10000000 per annum
担当コンサルタント Suguru Nakano
An international pharmaceutical company is seeking a Senior Global Safety & Pharmacovigilance Associate to join the team, whose primary responsibility will be processing and reviewing AS/SAE information received from sites for completeness and regulatory compliance.
- Process adverse event reports received from sites/reporters; perform QC reviews of completed individual and periodic reports
- Complete data entry including writing adverse event narratives and provide preliminary assessments of event seriousness as per applicable reference safety information
- Ensure case files are compliant with SOPs
- Distribute safety data reports to clients and other relevant parties; lead in the development of case management related SOPs and operating guides
- Supervise, coach, and mentor staff
- A bachelor's degree, preferably in life science, nursing, or pharmaceutical, plus 5 years of relevant experience, including 3 years of relevant safety/PV experience; experience could include data management, CRA, clinical practice, regulatory authority, or study coordinator
- In lieu of degree or healthcare professional license/certification, a total of 6 years' safety/PV experience may be considered
- Familiarity with safety database systems, ARISg or Argus preferred
- A detail-oriented team player
- Excellent communication, presentation, and interpersonal skills, both written and verbal, with an ability to inform, convince, and persuade
About the Company:
A global pharmaceutical company whose aim is to contribute to the health and well-being of its customers and healthcare communities worldwide through its innovative products and solutions, from cardiovascular medication and oncology drugs to clinical trials and research. This is a company committed to building a workplace that values diversity and develops/appreciates the skills of its talented global workforce.