Sr Associate Global Safety_PVの求人情報なら転職エージェントJAC


Sr Associate Global Safety_PV

  • 転勤なし
  • 週休二日制
  • 上場
  • 外資



会社名 外資製薬メーカー <業種:メディカル・バイオ - 製薬>


雇用形態 正社員(期間の定めなし)
勤務地 東京都

Group Purpose

Facilitate patient access to our products in Japan through the following: compliance with applicable local regulations; development and maintenance of local business processes in pharmacovigilance (PV) and post marketing surveillance (PMS), integrated in relevant our processes; development and execution of Japan risk management plan (J-RMP); assessment of safety data in Japan; provision of safety expertise; leading and collaborating on post marketing surveillance (PMS) activities; interface with regulatory agencies and industry organization; alignment with key cross-functional partners and business partners; continuous improvement of business processes

Job Summary

The Japan Safety PV Sr Assoc is responsible for: processing adverse event cases for local regulatory submission and advising Safety Associate on case processing; triaging medical literature and measure taken information for local regulatory reporting; drafting periodic safety reports; escalating safety data quality issues; and assisting the senior PV staff regarding a full range of safety activities.

Key Activities

Perform the following tasks, under the direction and guidance of the Japan Safety PV Sr Mgr:

Process adverse event cases and report them to the Health Authority

Triage literature and measure taken information and send it to assigned vendor

Review the contents of global periodic reports (e.g., DSUR, PBRER) from the headquarters and draft corresponding local periodic reports

Provide review and QC of safety data in study and product documents for regulatory submission

Translate safety case data between English and Japanese as needed

Process safety case data in the safety system

Serve as a point of contact for day-to-day issues management for assigned vendor

Communicate individual case processing and regulatory submission timelines to assigned vendor

Support audits and inspections

Support the senior PV staff on full range of safety activities



Understanding of local regulatory requirements for pharmacovigilance

Competence in safety systems and medical coding

Reading and written communication skills in both Japanese and English

General understanding of industry practices and standards


年収 800万円 - 1100万円
Reading and written communication skills in both Japanese and English