Case Operation Lead - Pharmaceutical Company

勤務地 Osaka, Japan
職種 正社員
給与 ¥10000000.00 - ¥14500000.00 per annum
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
Sub-specialization 安全性試験 / 安全性管理,
お問合せ Reid Aune
参照 JO-2007-444165
about Reid Aune

[Company Description]
Global Pharmaceutical Company

[Responsibilities]

  1. Manage and lead the J-GVP verification (final Adverse Event evaluation) staff members. Contributes to the resource planning and manage the workload balancing for the J-GVP verification case processing.
  2. Assess drug/device reportability and assign local labeling status (expected or unexpected) in order to achieve the appropriate case reporting status for Regulatory Agency reporting.
  3. Ensure medical plausibility, consistency and completeness of ADR (Adverse Reaction) / Malfunction case reports. Request follow-up information, and initiate use of specific product/event-related questionnaires when necessary.
  4. Provide input related to AE/SAE(Serious AE)/Malfunction case processing into global/local SOPs, global/local work procedures, the global/local user manual for the global database and other global/local process documents.
  5. Provide guidance on complex case handling issues which have been escalated by team members (if necessary involve medical subject matter experts)
  6. Ensure participation in global AE/SAE reporting compliance analysis appropriate corrective and preventive actions (CAPA) including corresponding documentation.
  7. Liaise with the global/local PV teams (e.g. Standards, Evaluation, SCPJ, J-Risk Management, J-PMS and J-medical governance) to support the definition of local specific needs for AE/SAE case evaluation.

[Requirements]

  • Bachelor's Degree or above
  • A minimum of 5 years of Pharmacovigilance experience
  • 8 years of relevant healthcare experience
  • People management experience.
  • Fluency in English (verbally and in writing). Must be able to fluently communicate with colleagues from PV data entry sites.
  • Should have or quickly develop basic knowledge of ICH principles of AE/SAE reporting along with basic understanding of local and global regulatory rules and regulations and basic knowledge of safety policies and procedures in the major countries.
  • Proactive behavior and ability to keep timelines
  • Incumbent must possess the ability to lead staff in changing times as well as strong interpersonal skills in the management and development of people in a changing environment communication skills are essential
  • Must possess good medical/clinical interpretation skills based on potentially limited information provided along with a comprehensive understanding of medical terminology.
  • Should possess well established decision-making and organizational skills, along with practiced training skills.
  • Ability to identify problems in case evaluation and to assist in the design workable solutions.

[Desired Characteristics]

  • 顧客との強固な関係を構築し、顧客の立場に立った解決策を提供できる。
  • 共通の目標を達成するために、周囲と信頼関係を構築し、協力して業務を遂行できる。
  • 複雑で大量の、ときには相互に矛盾する情報について把握したうえで効果的に問題を解決できる。
  • 共通の目標を達成するために、多様なスキルやものの見方を活用できるような強い一体感を持ったチームを作れる。
  • 説得力のあるビジョンと戦略を描くことで、周りの人々を動機づけ、行動を起こさせることができる。

[Employment Type]
Full time

[Salary]
10M-14.5M yen
※Experiences and skills will be considered

[Location]
Osaka

[Work Hours]
9:00-17:30


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