长沙招聘

RESPONSIBILITIE

Adverse Event Reporting:

1. Ensures that local processes, procedures and systems are in place for recording, processing, conducting follow up and translating adverse events and other safety information reportable to PPS from spontaneous and solicited sources.

2. Ensures comprehensive data collection and follow-up for all case types including Post-Marketing Observational Studies (PMOS).

3. Ensures local language medical or scientific literature are reviewed to identify possible adverse events or special situations reportable to PPS, and that any reports are reported in a timely manner to PPS.

4. Ensures that local processes are in place for translating and formatting CIOMS form into local language and local regulatory format, and that any reports are reported in a timely manner to local authority.

5. Implements an appropriate local QC procedure to ensure quality of information entered in Affiliate AE tracking log, cases sent to PPS and of reporting decisions to local regulatory authority.

Aggregate Safety Reporting:

1. Co-ordinates Affiliate review and submission of PSURs and other locally required Aggregate Safety Reports.

Reconciliation of Safety Data and Product Complaints:

1. Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures and forwards any AEs identified to PPS.

2. Completes AE reconciliation with interacting departments and/or partner companies (if applicable) and acts upon any discrepancies.

Organized Data Collection Programs (including Patient Support, Market Research, and Social Media Programs):

1. Ensures that all Organized Data Collection Programs are assessed for impact to adverse event generation and PV requirements are in place and in line with Global and Local SOPs.

2. Ensures that any new programs or any significant changes in existing programs are tracked and updated in the ODC inventories.

3. Ensures that proposed audits of Organized Data Collection Programs service providers/vendors are communicated to AVE and R&D QA PV Compliance prior to audit.

Safety Data Exchange Agreements (SDEA) and other PV Agreements:

1. Maintains compliance with local agreements, and ensures the content of local SDEA and other PV agreements conforms to AbbVie standards and local requirements.

2. Responsible for requesting or providing a copy of all adverse event files for local product acquisition and divestitures.

Training:

1. Ensures all Affiliate employees and contractors in Affiliate are aware of their responsibility to complete annual AE identification and reporting training. Ensures this training is completed.

2. Ensures training of Affiliate personnel on relevant PV responsibilities is undertaken at least annually, and that appropriate training records are maintained.

3. Ensures evidence of compliance related to this training.

4. Ensures that any training of partner company staff is completed according to local contracted requirements, and appropriately documented.

Audits and Inspections:

1. Acts as one of the key Affiliate contacts for both internal PV audits and Regulatory Authority PV inspections.

2. Ensures that any Regulatory Authority communications are forwarded to the required PPS personnel and that any responses / corrective actions are completed according to schedule.

Risk Management:

1. Reviews all Risk Management Plans and PSURs to obtain information on the risk/benefit profile of products.

2. Ensures local RMP Plans are appropriately designed and implemented. Ensures risk minimization activities are properly tracked.

Compliance:

1. Ensures an Exception Report / CAPA process is in place to manage any non-conformity.

2. Monitors, notifies and assesses all draft and final hard PV intelligence in line with global timelines and requirements.

3. Ensures local deviation procedure is in place to document necessary planned departures from global and local PV related procedures.

After Hours Availability:

1. Ensures that an after-hours process is in place, tested at least once every 3 months and results are documented.

2. Maintains up- to-date information on local Regulatory Authority out of hour’s contacts.

Business Continuity:

1. Ensures that a Disaster Recovery Plan/Business Continuity Plan is established in a risk-based manner to allow for continuation of critical business processes for PV. The plan should include provisions for events that could severely impact the organization’s staff and infrastructure in general or on the structures and processes for PV. This includes back-up systems for urgent exchange of information within an organization, amongst organizations sharing pharmacovigilance tasks and between marketing authorization holders and competent authorities.

IDEAL CANDIDATE:

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

• Minimum of two years’ experience working in the pharmaceutical industry in a drug safety role is strongly preferred.

• Excellent written and spoken communication and presentation skills.

• Fluency in written and oral English is essential in order to facilitate communications with Pharmacovigilance and Patient Safety, Regional Medical and other headquarters functions.

• Fluency in written and oral local language a requirement in order to facilitate communications within the affiliate medical department, and with the National Regulatory 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.

关于艾伯维中国

艾伯维（纽约证交所:ABBV）是一家于2013年1月2日正式成立的全球研究型生物制药公司，从雅培公司拆分而来。 艾伯维将尖端生物科技与百年传承的专注、激情，以及专业技术和组织架构集于一身，凭借其专业技术、敬业的员工和独特的创新方式，旨在研发并推广先进治疗方法，解决世界范围内的一些疑难杂症。2013年，全新成立的艾伯维在全球范围内拥有近21,000名员工，产品销往170多个国家。

艾伯维已在中国正式注册成为一家外商独资的医药公司,并且于2013年6月1日完成与雅培中国的拆分。艾伯维中国的产品线涉及多个疾病领域，涵盖免疫学领域、抗病毒学领域、肾脏学领域以及麻醉学领域。同时，艾伯维与中国的医学界和政府部门紧密合作，共同开展覆盖丙肝、肿瘤、免疫学、神经科学、疼痛和妇科健康等领域的临床研究。

艾伯维中国介绍

中国总部    上海

研发中心    艾伯维中国研发中心——上海张江研发中心，落成于2009年3月，是艾伯维全球7个研发中心之一。作为临床前研究的一环，支持全球药品研发中心（GPRD）的药物研发，主要集中在免疫、疼痛、神经系统与肾病领域。

员工数    近500名

历史 艾伯维中国成立于2013年6月1日

企业评级

艾伯维被纳入标准普尔500红利经典指数（S&P 500 Dividend Aristocrat Index） ，纳入这一指数的标准是公司股票连续25年以上实现持续增长的现金分红。同时， 艾伯维也被纳入标准普尔高产红利经典指数（S&P High Yield Dividend Aristocrats Index） ，纳入这一指数的标准是连续20年以上实现持续增长的现金分红。

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