衡阳招聘

Compliance –

• Ensure compliance with the CAPA process for the reporting and investigation of exceptions (nonconformance, potential nonconformance and planned deviations).

• Ensure a local tracking system is in place to ensure timely submissions of adverse events (AEs) to GMS.

• Ensure reporting of both clinical and post-marketing individual case safety reports (ICSRs) and periodic reports to the regulatory authority as required (and ethics committee, if applicable).

• Report monthly compliance metrics and information to QPPV Office, GMS, International PV, Compliance, Strategy and Analytics (CSA), and BQ within the required timelines

• Maintain awareness of local post-marketing and clinical PV legislation and guidelines

• Ensure Line Manager/APAC Cross Sector Safety Lead, and PV Policy Group are promptly notified of any changes to relevant local legislation.

• Ensure formal documentation and notification to PV Policy Group of local reporting requirements for both ICSRs and aggregate reports, provide updates to these requirements per changes in local legislation, and review and confirm these requirements at least annually.

• Coordinate affiliate review and submission of PSURs & DSURs.

• Ensure any changes to affiliate safety personnel are communicated to the Health Authority (i.e. nominated contact person for PV), GMS, OCMS and IPV in a timely fashion.

• Complete AE reconciliation with interacting departments and/or partner companies (if applicable) and act upon any discrepancies

• Review and confirms regulatory reporting requirements at least bi-annually

  Processes & procedures –

• Ensure local processes and procedures are in place to clearly define PV responsibilities within the affiliate in line with global SOPs and local regulations.

• Ensure all local PV quality documents are reviewed and updated as applicable at minimum every 3 years.

• Ensure all required documents related to PV departmental activities are retained according to SOPs and regulatory requirements.

• Review any changes to global quality documents and perform and track impact assessment on local quality documents; implement change management in a timely manner according to global requirements.

  PV Agreements

• Maintain compliance with local agreements, including reconciliation between partner companies and vendors.

• Ensure the content of local PVA and other PV agreements conforms to J&J standards per global and local requirements.

• Submit all local PVAs to PV Legal for review prior to finalization.

• Submit all other local PV agreements to PV Legal for review prior to finalization if these agreements contain variations from the PV agreement language templates.

• Responsible for requesting or providing a copy of all AE files for local product acquisition and divestitures.

• Submit all approved local PV agreements in the PV agreements database for central tracking.

• Ensure any changes to local PV agreements (e.g. changes in contact information; terminations) are updated in the PV agreements database

• Responsible for maintaining the inventory of local PV agreements and their respective product list and status within the PV Agreements Database

• Maintain the inventory of all local PV agreements within the PV agreements database, including current status and a list of applicable products.

• Ensure a local tracking system is in place to monitor compliance with local safety data exchange timeframes.

• At a minimum quarterly, reconcile local PV agreements with the PV agreements database (e.g. International Contracts Database), and complete an attestation documenting this review in the PV agreements database.

• Maintain and update inventory of all local PV agreements within the PSMF, including current status and list of applicable products

  Research Related Activities (RRA)–

• Ensure that all RRA programs are assessed for impact to AE generation and PV requirements are in place and in line with global and local SOPs.

• Ensure that any new programs or any significant changes in existing programs are tracked and updated in the Trial Master Source (TMS) and HIVE inventory.

• Ensure training on PV obligations is conducted for all J&J and service provider staff involved in RRA programs with annual refresher training.

• Monitor the service provider to ensure PV obligations are being fulfilled, including appropriate collection, follow up and reconciliation of safety information according to local procedures.

• Oversee vendor quality assessments of relevant service providers are performed.

• Ensure that proposed audits of RRA program service providers/vendors are communicated to relevant stakeholders prior to audit.

• Support local BQ to conduct vendor audits and complete vendor Corrective Action Plans (CAPAs).

• Maintain and update inventory of all local RRA within the PSMF, including current status and list of applicable products

  Collaborate & Support

• Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups as appropriate. Collaborate with appropriate departments to identify the resources and expertise needed to address the question. This may include local, regional and/or global expertise.

• Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols to ensure appropriate safety reporting to GMS or appropriate case management centre and Health Authority, as required.

• Where applicable, support the Qualified Person Pharmacovigilance (QPPV) to provide safety-related regulatory communication (e.g., response to request for information from local Health Authority, including the provision of information about the volume of sales or prescription, as appropriate.

• Participate in the Product Issue Management teams, as appropriate.

• Provide technical and strategic input and participate in projects led by the regional GMS team and GMS work streams.

  Training –

• Maintain a version-controlled training matrix/plan for local PV personnel which includes, but is not limited to, local SOPs, local regulations and references to the global affiliate PV courses allocated in ComplianceWire (CW) and SUMMIT.

• Ensure training compliance with GMO and local PV training requirements and other mandatory training as required by GMO.

• Ensure all Affiliate employees and contractors for all countries the LSO s responsible for (including Global or Regional staff based at the LOC) are aware of their responsibility to complete annual adverse event identification and reporting training. This PV training is to be undertaken at least annually, and appropriate training records shall be maintained. Ensure this training is completed.

• Ensure that any training of partner company and vendor staff is completed according to local contract requirements, and appropriately documented

  Audit & inspection readiness –

• Lead the audit / inspection preparations for internal PV audits, Johnson & Johnson Regulatory Compliance (JJRC) and Bioresearch, Quality & Compliance (BRQC) inspections.

• Act as the key affiliate contact for all PV audits.

• Lead the review of documents prior to and during PV audits and inspections.

• Ensure that any Health Authority communications are forwarded to the required PV personnel and that any responses/corrective actions are tracked and completed according to schedule.

• Ensure PV inspection readiness at the affiliate level at all times.

  Business Continuity–

• Ensure that a process is in place for reporting of AEs after hours, and testing is documented as per Global and Regional requirements

• Ensure that a disaster recovery /business continuity plan is established in a risk-based manner to allow for continuation of critical business processes for PV

  Filing & archiving –

• File all source documents and other safety-related documents according to local and global requirements

• Archive documents periodically as necessary

Qualification：

• Medical, pharmacy or life-sciences degree (or equivalent)

• 2-3 years of experience in PV essential; experience working in the pharmaceutical industry is strongly preferred

• Extensive experience in conducting training

• Knowledge of PV regulations

• Experience using global safety database desirable

• Demonstrated attention to detail

• Excellent written and spoken communication and presentation skills

• Effective decision maker with the ability to assess impact of actions taken locally on the global PV system

• Fluency in written and oral English in order to facilitate communications with GMO, regional Medical, other global functions, and Health Authority

• High customer orientation

• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity

• Sound judgment, strong planning and organizational skills, and the ability to get things done

• Demonstrated strong sense of urgency

Strong influencing skills with the ability to explain and defend a position which is in the best interests of patient safety

公司简介(中文) 恢复为 “成立于1985年的西安杨森制药有限公司（“西安杨森”）是中国***的合资制药企业之一，也是中国改革开放以来进入中国的最早一批制药公司之一，其总部位于北京的中央商业区。西安杨森是强生公司的一员。从创立之初，西安杨森就致力于引进和生产许多创新产品和高质量产品。西安杨森一直致力于投资未来，计划增加在生物制品、心脏病学、风湿病学和泌尿科学领域的新系列产品。西安杨森致力于利用这些新药改善中国患者的医疗保健状况。

本着公司信条和关爱精神，西安杨森一直是活跃的企业公民，在医药、公共卫生、药物研发领域和企业社会责任方面从事了五十多项合作项目。例如，西安杨森与中国卫生部国际卫生交流与合作中心合作创立了“吴阶平医学研究奖和保罗•杨森药学研究奖”，旨在鼓励医药学领域的工作者不断创新。在过去的17年中，共计305名杰出医药学工作者在45个专业领域获得了该奖项，他们在科研领域做出了大量有价值的创新。 此外，西安杨森也被誉为培养制药行业人才的摇篮。1999年，西安杨森被财富杂志（中文版）评选为“中国最受敬仰的十大外资企业之一”。2005年，西安杨森被中国中央电视台评选为“***雇主”，并且分别在2008年、2009年和2010年获得了“中国大学生***雇主奖”。

目前西安杨森所有的招聘信息仅通过前程无忧，智联招聘和猎聘网进行发布，任何在非上述三家招聘网站看到的信息均非西安杨森正式发布。为避免对您的合法权益造成伤害，请务必通过正规渠道投递简历。

2013年，强生在西安高新区投资兴建强生全球供应链先进的生产基地，该项目建设目前已正式启动。新生产基地占地267,000平方米，将取代西安杨森在西安新城区现有的生产基地，成为强生供应链在亚洲的创新枢纽，从而更好地满足中国和其他新兴市场不断增长的需求。新的生产基地将采用世界***的制造技术和先进的质量体系，并引进集电子批号记录和数据存储于一身的全自动化配方生产操作系统以及先进的德国进口生产工艺设备。