求職服務專線
台北 02-2912-6104 轉 2
   02-7703-3104 轉 2
意見回饋
廠商求才專線
台北 02-2912-6104
   02-7703-3104
台中 04-3700-6104
上海 86-21-50277104 轉 1
意見回饋

Pharmacovigilance, Medical Governance & Operations Manager

  • 全職

Primary Objective of Position:
The position ensures organizational compliance to GSK Policies & Standard Operating Procedures and local Regulatory Authority Guidelines in the areas of Pharmacovigilance, Human Safety Issues and Medical Information, together with identification/ implementation of suitable risk mitigation strategies for maintaining high governance standards.

• Represent and assist the Country Medical Director to ensure collaboration on planning and execution of all clinical & pharmacovigilance activities alongside internal stakeholders
• Member of the LOC medical leadership team, and ?risk management committee board.
• Assisting to collate information on behalf of the Medical Director, including periodic management monitoring, updates to risk registry/checklist and medical KPIs/matrixes.
• Designated Country Medical Information Champion with overall management of the operational and governance of Medical Information Process, including training of new Medical Affairs Managers or Field Medical Managers on how to use the MI system and SOP’s, as well as liaising with Global MI teams to ensure compliance and conformity to the global MI Process.
• Designated Country Lead for Clinical Trials with overall management and oversight of all clinical trials occurring in Taiwan for GSK sponsored and investigator sponsored trials.
• Point of contact for local regulatory authority on PV related matters.
Training of all operating company staff & 3rd party service providers who require PV Training (including but not limited to Market Research Agencies, 3rd party sales forces, those providing services under Patient Support Programmes and Interactive Digital Media)
• Supports the General Manager, Country Medical Director, and Person Responsible for Pharmacovigilance in awareness and delivery of their pharmacovigilance responsibilities under corporate policies, standard operating procedures, and regulatory requirements
• Identify and implement appropriate safety processes and systems for effective business operations and corporate and regulatory compliance such as the labelling process requirements
• Assist regulatory unit and the LOC in terms of implementation of the GDS (if required)
• Monitor and improve the current level of activities in pharmacovigilance and ensure consistency and compliance with corporate policies, standard operating procedures, and regulatory requirements to protect patients, GSK’s products, and GSK’s reputation
• Coordinate GSK Taiwan planning and preparations for corporate and regulatory pharmacovigilance audits
• Manage the handling and reporting of all pharmacovigilance related matters used in clinical trials, compassionate use programs and for marketed products
• Support other departments in safety issues, i.e. participate in the preparation of risk minimisation programs and post-commitment issues.
• Active involvement in internal and external developments through close internal interactions and through participation in external safety meetings and assessment of external national safety information
• Generation and implementation of Pharmacovigilance Level 1 Self Inspection programme.
• Providing pharmacovigilance support for the legal teams when developing contracts/ agreements requiring PV Clauses or Safety Data Exchange Agreements.
• Mentoring and coaching of Associate NSC
• Performance tracking of the Named Safety Contact Back-up.
• Training of the project team about safety requirements of the study.
• INDSR reporting: It includes reporting of Initial occurrence of an SAE, its follow-up information to the Investigator, to the relevant regulatory authorities and to other participating sites within the timelines of local regulations and internal advice.
• To liaise with clinical team to ensure that clinical trials updates are communicated to the Named Safety Contact for proper dissemination of information to sites and regulatory authorities

工作條件

  • 接受身份: 上班族
  • 工作經歷: 七年以上
  • 學歷要求: 碩士
  • 語文條件: 英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
  • 其它條件: Experience / Knowledge / Technical Skills Required:
     Adequate medical and pharmaceutical knowledge
     At least one year’s experience in medical function of pharmaceutical industry or related fields (ADR Reporting Centre, Pharmacist in hospitals)
     Strong analytical skills
     Experienced in safety reporting function
     Experienced in risk management is a plus
     Good command of both spoken & written English
     Good communication skills

福利制度

[正職人員]
1. 週休二日
2. 年休假10天以上
3. 享勞保.健保及團保(配偶及子女)
4. 員工健康檢查
5. 年度旅遊
6. 三節禮金,結婚及生育禮金
7. 績效獎金
8. 完整的教育訓練計劃
9. 業務行銷同仁購車無息貸款

[約聘人員]
比照勞基法

更新日期:2020-11-21

應徵方式

  • 職務聯絡人: Trinity
  • 聯絡E-Mail: (請利用104履歷表應徵此工作) 我要應徵
  • 洽: 不接受電洽
  • 洽: 不接受親洽

應徵分析

兩週內6-10人應徵
經歷分佈
新鮮人14%
1~3年14%
3~5年14%
5~10年0%
10年以上43%
學歷分佈
碩士及以上57%
大學43%
專科0%
高中0%
高中以下0%

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