Senior GSPV associate(Global Safety & Pharmacovigilance)7月16日入社予定の求人情報なら転職エージェントJAC


Senior GSPV associate(Global Safety & Pharmacovigilance)7月16日入社予定

  • 転勤なし
  • 週休二日制
  • 外資



会社名 サイネオス・ヘルス合同会社 <業種:メディカル・バイオ - CSO>


雇用形態 正社員(期間の定めなし)
勤務地 大阪府 東京都

Senior GSPV associate













Primary function:

This position is responsible for processing and reviewing AE/SAE information in domestic and overseas safety cases received from Manufacturing Authorization Holders (MAHs), medical institutions, and regulatory authorities for completeness and regulatory compliance.

-Process adverse event case information received from medical sites/reporters, and MAHs

-Perform quality control review of completed individual cases and periodic safety reports

-Complete pre-intake, triage, assessment, validation, finalization, and translations including writing of adverse event narrative and provide the final assessment of event seriousness and expectedness/listedness as per applicable Reference Safety Information

-Prepare ADR reports and E2B files for regulatory submission

-Generate adverse event queries, liaise with the medical reviewers/the MAH to agree upon the queries, and send request for additional information to the sites/reporter

-Engage with the Site Monitors and MRs to ensure follow-up information is obtained from medical institutions effectively

-Foster constructive and professional working relationships with all project team members, internal and external

-File documents report results, and store records according to project specific requirements (electronically or in hard copy as applicable)

-Ensure safety management activities are compliant with SOPs and regulations

-Distribute safety date reports to team members for medical assessments and reviews

-Distribute safety data reports to Safety Managers, the MAH, and other relevant parties

-Responsible for ensuring project deliverables are completed on time and with high quality

-Participate in the development of safety SOPs and Operating Guides

-Participate in project meetings with local and global GS&PV team members as required

-Participate in audits as required/appropriate

-Mentor and train other associates on procedu


■休日:完全週休二日制 年末年始


<Senior GSPV associate>





-Bachelor’s Degree in a life science or nursing

-Five years of experience with clinical trials, may include data management, CRA, clinical practice (RN, RPN), health authority or study coordinator experience

-Three years of Safety/Pharmacovigilance experience

-Excellent verbal and written communication skills, including business level English (reading/writing)

-Experience with safety database systems: Perceive, E2B Writer, Clinical Works, ARISg or Argus preferred

-Ability to work as part of a team and across geographical locations

-Possesses a positive attitude and works well with others


年収 400万円 - 900万円