长沙招聘

The Local Patient Safety Associate (LPSA) is directly accountable for performing all pharmacovigilance (PV) tasks allocated to the Local Patient Safety organization under the supervision of the Local Patient Safety Officer (LPSO) in a given country/territory. Tasks have to be performed in full compliance with all relevant global and local regulatory requirements and company standards. This includes:   1.       Product safety surveillance ·       Handling of all local safety information, including collection, registration, translation from local language into English, and transmission to GPS as applicable in a timely manner ·       Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner ·       Performing screening of relevant local medical/scientific literature in accordance with GPS procedures and local requirements ·       Performing screening of relevant local health authority web sites according to global standards as defined by relevant quality documents ·       Collaboration with medical information, quality assurance, complaint management and PDCSs to ensure safety reporting procedures are in place, safety relevant information is processed in a timely manner, and reconciliation is completed ·       Keeping product knowledge up-to-date to ensure appropriate Individual Case Safety Report (ICSR) handling ·       Performing required safety activities in the absence of the LPSO   2.       Reporting to local Health Authorities and Ethics Committees ·       Timely submission of expedited ICSRs to concerned local health authorities (where applicable) ·       Support of e-reporting in e-reporting ready countries (where applicable) ·       Timely submission of expedited cases to concerned local/central EC/IRBs as applicable ·       Timely submission of safety issue reports to concerned local health authorities ·       Timely submission of safety issue reports to concerned local/central EC/IRBs as applicable   3.       Compliance related activities   ·       Using applicable tools (e.g. IRT) to ensure local compliance in terms of ICSR handling according to local regulations and company timelines ·       Supporting the LPSO to ensure compliance reports to GPS via the applicable technical tool (e.g. SCCT) in a timely manner ·       Contributions to the Local PV file in close collaboration with cross-functions to support completeness, accuracy and that relevant information is updated in a timely manner   4.       Tracking of clinical development and Patient Data Collection Systems (PDCS) activities in the assigned countries ·       Supporting the LPSO that a complete overview on local / global clinical studies and PDCS (planned as well as ongoing) in the local affiliate is kept ·       Supporting the LPSO that current global procedures for the handling of PDCS and clinical studies are followed     5.       Training activities ·      Completion of all mandatory PV trainings in a timely manner ·      Supporting PV training activities under the supervision of the LPSO ·      Supporting the LPSO in PV related trainings as required

FINANCIAL DIMENSION

Major financial impact: Non-conformity to regulatory authority obligations may have significant negative implications on drug development programs and/or marketing authorizations STRATEGIC IMPACT Not applicable SCOPE OF PEOPLE RESPONSIBILITY Not applicable COOPERATION Internal within GPS: ·         GPS Regions, GPS Operations, GPS Life Cycle Management, GPS Compliance and Standards   External to GPS: ·         Medical Affairs, Commercial, Regulatory Affairs, Government Affairs, Quality Assurance within the countries and within the Region, Health Authorities, Ethics Committees as applicable. CANDIDATE’S PROFILE   EDUCATION ·         Medical, pharmaceutical or health care background or relevant working experience ·         Fluent in written and spoken local language and English WORK EXPERIENCE ?       Experience in in the pharmaceutical industry or health authority (thereof 2-3 years in patient safety) ?       Good knowledge of local regulatory PV legislation ?       Good understanding of drug development and life-cycle management JOB-SPECIFIC COMPETENCIES & SKILLS      ·         Strong intercultural skills (developed from practical experience) ·         Strong team-working skills – working across cultural and functional boundaries, and participating ‘virtual teams’ ·         Good problem-solving and decision-making ability ·         Good organizational skills, ability to prioritize work and adapt rapidly to changing priorities ·         Ability to manage multiple situations/issues under time pressure ·         Effective presentation and training skills ADA REQUIREMENTS (mandatory for US employees) ·         Normal and routine office duties ·         Position requires both domestic and international travel up to 10% of time             

北京外企德科人力资源服务上海有限公司（简称 FESCO Adecco 外企德科）是中国人力资源服务行业具竞争力和品牌价值的FESCO与全球人力资源服务行业领航者Adecco成立的一家中外合资人力资源服务企业，为企业及个人提供业务外包、人事服务、招聘猎头和员工福利等相关人力资源解决方案。

成立于1979年，FESCO拥有悠久的人力资源专业化服务历史、丰富的市场经验以及完备的服务资质，是中国人力资源服务行业的领跑者，Adecco则是全球人力资源行业的巨头，服务网络遍布全球60多个国家和地区。FESCO Adecco成立后，双方通过优势互补，整合了客户资源，依托全球化的资源和服务平台，融合本土网络优势，扩大了业务范围，为客户提供全方位的业务流程外包（BPO）、财务外包与薪酬管理、人事委托/人事派遣、全球化派遣、人才招聘/RPO相关服务、健康福利与弹性福利等人力资源解决方案。合资后的FESCO Adecco飞速发展，并且在浙江、重庆、深圳、苏州设立了分支机构。目前，FESCO Adecco在中国每天服务达100万名员工，服务客户近12,000家。

FESCO Adecco致力于成为***的人力资源全面解决方案提供商，成为客户最值得信赖的人力资源合作伙伴。为客户打开通向国际市场及创新型人力资源服务模式的大门，推动中国乃至全球的人力资源外包产业的健康发展。