Case Management, Drug Safety Managementの求人情報なら転職エージェントJAC

求人情報

Case Management, Drug Safety Management

  • 転勤なし
  • 週休二日制
  • 外資
求人番号

NJB1032265

[無料]転職サポートのお申し込み

会社名 社名非公開 <業種:メディカル・バイオ - 製薬>
職種

メディカル・バイオ-安全性情報(臨床開発/製販後GVP)

雇用形態 正社員(期間の定めなし)
勤務地 東京都
仕事内容

AE CASE MANAGEMENT

・ Data Entry, Assessment, Triage, Regulatory Reportability & Distribution

・ Execute triage of cases: Determine the follow up or new case per medical and temporal criteria, Identify and assess all AEs for seriousness, Identify pregnancy case, Make follow up call if critical information is needed to determine AE seriousness, ecalate report internally within drug safety as needed

・ Conduct full data entry from source document

・ Execute QC on key fields of serious cases and update ARISg as needed

・ Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)

・ Identify SUSARs from blinded clinical studies and alert Drug Safety Management to the need for unblinding

・ Create narrative as defined by conventions

・ Create draft company comments for serious cases

・ Rank events and determine dechallenge/rechallenge information

・ Develop follow-up needs for AE reports and create follow-up letters, review and update generated follow-up letters as appropriate

・ Update communication log in ARISg as needed

・ Authorise (approve) non-serious cases

・ Notify Workflow/Drug Safety Manager if any delay in case processing is observed

・ Review and resolve ARISg validation errors

・ Determine regulatory reportability based on case characteristics and regulatory requirements

・ Contribute to the maintenance of a regulatory reportability matrix and other supporting documentation


■休日:完全週休二日制

求める経験、能力
年齢制限の理由

・ Experience

・ Two (2) years relevant clinical experience or relevant scientific background equivalency

・ Two (2) years relevant experience in the Industry, drug safety experience preferred

・ Data entry/data management or document management experience


■職種未経験者:不可

年収 600万円 - 900万円
語学力
英語力: 
中級

ご経験・スキルを考慮したうえで、非公開求人も含めた最適な求人のご紹介もいたします。
下記ボタンよりお申し込みのうえ、キャリアコンサルタントにご相談ください。
※既に当社にご登録いただいている方はこちらをご覧ください。


[無料]転職サポートのお申し込み

新規登録


ページの先頭へ戻る