【立ち上げ・外資メガーバイオベンチャー】Global PV Associate Managerの転職・求人情報 29854497

募集要項

仕事内容: こんな方なら向いている
―　外資メガーバイオベンチャーが初日本市場参入したフェーズにおいてグローバルカウンターパートと近い距離で日本安全部門の立ち上げ経験を積みたい人
ー　一般的なPV業務のほかに、手順書領域での経験を深めたい人
ー　意思決定のスピード感が速く、革新的な技術をもっている企業
ー　柔軟的な働き方をしながら申請業務に携わりたい方（ハイブリッド勤務＋スーパーフレックスタイム制、コアタイムなし）

About the Job:
We are looking for an Associate Manager, Global Patient Safety, with a good background in GVP operational experience. This role will provide an opportunity to ensure our systems matter by updating procedures with our Japanese partners and working on local SOPs. We are a small yet multifaceted organization on the path of consistent expansion, where each team member’s contribution is invaluable. Join us in building an environment where your insights can contribute to our direction and impact in the industry.

応募資格

必須: － Bachelor’s degree or equivalent experience （BS degree preferred）
－ At least 3 years of relevant pharmacovigilance experience in the pharmaceutical or biotech industry.
－ Proven understanding of relevant PMDA/MHLW and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post－marketing environments required.
－ Contributes to and leads organizational projects and goals to support their timely completion.
－ Proficiency in supporting regulatory authority inspection such as PMDA Re－examination, MAH license renews and GCP Reliability Inspection.

歓迎: － Expertise in working on complex projects, such as function/team improvement projects, Safety Database implementation projects, Business license succession including safety data transfers.

キャリアパス・評価制度: 将来は社内においてマネージャー、シニアマネージャーへの昇進、部下管理マネージャー及び部下なしマネージャーへの方向性両方視野にはいっている