医療・医薬の医薬品 in 東京都

posted
job type
正社員
salary
¥ 9,000,000 年棒
apply now

job details

posted
location
東京都
job category
医薬品・医療機器
job type
正社員
salary
¥ 9,000,000 年棒
experience
・Over 5 years of experience in PMS or related work experience. ・Experience of re-examination applica
reference number
55448-13
apply now

job description

社名
社名非公開

職種
医薬品

業務内容

1. Post marketing surveillance



  •  Creating PMS execution plans in the Risk Management Plan.

  •  Drafting CRFs for PMS.

  •  Implementing PMS.

  •  Oversee the development, implementation and enforcement of PMS, including data collection, analysis and summary of results.

  •  Educating sales staffs regarding PMS.

  •  Creating a J-PSUR (surveillance part).

  •  Establish proper collection of safety information from MRs.

  •  Review reports which will be submitted to the Japanese Regulatory Authority.

  •  Prepare and revise local SOP related and PMS(GPSP).

  •  Contribute to establish and maintain good relationship with regulatory agency.

  •  Continuously improve overall work process .

  •  Influence business decisions by other department to keep safety high priority for the business..


2. Risk Management Plan



  • Creating risk management plan (PMS part) in collaboration with person in charge of J-RMP


3. Cooperation with CRO



  • Selection of CRO.

  • Managing CRO’s operation.

  • Auditing CRO’s operation.

  • Requesting improvement of CRO’s operation, if needed.


4. Support and liaison to other functions



  • Support publication activities for Medical Affairs on PMS.


 



求められる経験
・Over 5 years of experience in PMS or related work experience.
・Experience of re-examination applications and its inspections (twice or more are preferable).

給与
年収900 ~ 1300万円

skills

・Pharmaceutical and Scientific knowledge of SOP, GPSP.
・Organizational skills to manage multiple projects simultaneously.
・Demonstrates excellent attention to teamwork and initiative.