长沙招聘

Responsibilities:

    

?Plan, conduct (individually and/or as part of a team) and report assigned Pharmacovigilance (PV) audits to Local companies/ Local Affiliate/ 3rd party: PV vendors/ PV distributors, in order to ensure compliance with relevant guidelines, legal requirements, GVP, and/or other relevant GxPs. Support global GxP related audits as needed.

    

?Analyze audit observations to help to improve processes in Pharmacovigilance and respective interfacing functions. Follow up on CAPAs resulting from audits and deviations as assigned.

    

?Provide customers with advice/ consults regarding applicable GxP and/or compliance related issues and questions. Investigate and/or escalate compliance problems and questions from Pharmacovigilance and other applicable customers.

    

 ?Assist the PV Manager in developing, managing and executing the PV Audit Program, forecasting audit demand, and managing the PV Quality System and CAPA Program. Support of other GxP audit/activities, as needed

    

?Support maintenance and continuous improvement of PVQA/ Global R&D Quality System (processes, tools, etc.) of local clients.

    

 ?Support PV CAPA and deviation management as assigned.

    

?Serve as the primary point of PV Manager for the local clients staff ensuring the timely communication of quality risk and compliance as related to GVP.

    

    

    

KEY COMPETENCES

    

·        5+ years of experience in Pharmacovigilance area

    

·        2+ years of experience in PV quality assurance activities, in particular in PV auditing activity.

    

·        Knowledge of GVP regulation as well as 21 CFR and other applicable regulations.

    

·        Excellent interpersonal relations and written and verbal communication skills

    

·        Proven organizational skills with ability to manage multiple priorities in parallel

    

·        Flexible, adaptable, and able to react to changing circumstances and priorities

    

·        Displays a high level of commitment and professionalism

    

·        Maintains a ‘can-do’ attitude, collaborates effectively and contributes to a team-oriented culture; possesses strong work ethic and integrity

    

·        Fluent English

    

    

    

OTHER SKILLS

    

? Up to 60% availability to business travel

    

? People management / coaching

    

? Team-play

    

? Project management

    

? Time management

    

? Customer management

PQE公司成立于1998年，作为欧洲领头的整体质量打包解决方案服务公司，以200多名专家咨询师的优势，服务领域包括质量系统、合规注册和验证确认等领域。更致力于为客户提供数据完整性保障(Data Integrity Assuance）的整体解决方案。我们已在全球45个国家，参与或主持了8，000多个项目。我们的客户包括全球知名跨国企业和地方领头企业。我们是山德士、特瓦等公司的全球服务伙伴，同时也与赛诺菲、辉瑞、罗氏、诺华等知名制药企业保持长期稳定合作关系。

PQE目前已进入中国市场，服务中国企业。我们期望能成为一个成本最优、品质最高的服务咨询公司。将秉承We Act Locally,Think Globally的商业理念。