PMSマネージャー

Job Details

<求人タイトル>

18873 PMSマネージャー

<職務内容>

・Post Marketing Surveillance Manager of pharmaceutics or medical devices.
-To be overall responsible for planning, implementation and communication of PMS in accordance with GPSP requirement.
-Budgeting and CRO Management for PMS.
-Management of Post Marketing Surveillances with on-site and off-site vendors.
-To ensure planning and implementation of required GPSP training to the employees and others as appropriate.
・Safety management (Preparation of aggregate reports, Self-Inspection) of pharmaceuticals
and medical devices, collaborating with collaborating with head of Pharmacovigilance Japan and safety manager.
・Cross coverage (back up) to Pharma PV activities in the company
・To develop and maintain SOPs that follow local regulations and that support and are in accordance with corporate SOPs.
-To conduct self – inspections (GPSP) and work implement corrective action if necessary
・Educate GPSP and GVP knowledges to safety members including on-site vendors.
-To be familiar with GPSP and GVP guidelines and local regulatory regulations.
・Improvement of Japan safety team activities and procedures collaborating with head of
Pharmacovigilance Japan and safety manager.

<応募要件>

・Excellent Experiences of PMS management of pharmaceutics or medical devices and GVP management.
・Excellent Regulatory knowledges for GPSP (Good Post Marketing Surveillance Practice).
・Excellent analytical skills and ability for PMS results.
・Ability to work effectively and collaboratively across the global and local organizations and
cross-functionally.
・Highly motivated with interest in PMS, pharmacovigilance and risk management.
・Good interpersonal and negotiation skills
・Degree in, Pharmacy, Life sciences or equivalent.
・PMS experience
・Understanding of Risk Management principles and practices
・Understanding of global pharmacovigilance regulations
・PMS experience (implementation and utilization of PMS system in Japan)
・Experience working within multinational pharmaceutical companies
・Highly motivated with interest in PMS, pharmacovigilance and risk management
・Excellent analytical skills and ability to think strategically with global perspectives
・Ability to work effectively and collaboratively across the global and local organizations and
cross-functionally
・Excellent communication skills, both written and verbal

<会社概要>

グローバルに展開する医薬品・医療機器メーカーになります。多岐に渡る領域を専門とし豊富なパイプラインを有する企業ですが、特に美容医療ビジネスでは確率されたブランド力を持っています。

<注目ポイント>

今後の成長市場である領域にチャレンジいただけるまたとない機会です!高いブランド力を持つ企業で、ピープルマネジメントのご経験も積んでいただけます。ご興味がございましたら、是非お気軽にお問い合わせください!

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company