莆田招聘

收简历邮箱 pfizer_hr_north@pfizer.com

JOB SUMMARY

Review, analysis, preparation, and completion of safety-related reports within scope of the DSU to determine the safety profile of Pfizer’s products and to meet regulatory requirements. Provide specific pharmacovigilance knowledge and experience, as required by the business, and mentor colleagues accordingly. Manage resources in the safety team depending on local organization and safety group size.

KEY RESULT AREAS & JOB ACTIVITIES /TASKS

• Organize, manage, and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity.
• Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios
• Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
• Ensure complete and timely forwarding of ICSR to Core
• In collaboration with the Country Lead, ensure timely handling of local safety issues; manage local safety issues in collaboration with central safety functions and the local Medical Director/other platform functions/BU colleagues as required
• Monitor, and actively conduct as needed, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local regulatory authority
• Consistently apply regulatory requirements and Pfizer policies
• Analyze and monitor activities, define and implement corrective actions, where applicable.
• Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database.
• Provide oversight and team mentoring on case handling aspects, data extraction, and analyses.
• Support the Country Lead in organizing and managing the country safety group to ensure effective coverage of safety-related activities
• Support the implementation of corrective actions resulting from timeliness or quality issues associated with safety-related activities for the country
• Support the standardization and quality of safety data exchange agreements
• Support the organization and management of inspection readiness activities
• In collaboration with the Country Lead, monitor and manage training of DSU, and ensure coaching and mentoring are effective for colleagues to fulfill the daily work
• Support effective recruitment for the DSU; fully utilize corporate tools, to manage the performance reviews of assigned colleagues in the country
• Support the Country Lead in fulfilling of drug safety related obligations for the country
• Participate in above countries activities as DSU representative, as required by Country Lead
• Deputies for the Country Lead, as required, in the promotion of local, internal and external safety activities in collaboration with the Medical Director, other platform functions and BU colleagues
• Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across all WSRO DSU
• Act as subject matter expert for the DSU within WSRO
• Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners (e.g., BUs, License Partners) regarding safety data collection and handling
• Promote/participate, as appropriate, in local, internal and external safety activities

EDUCATION & EXPERIENCE REQUIREMENTS

1, Educational /Training

Bachelor degree or above, medical pharmacy or bio-science background is preferred.

2, Working Experiences

- Minimum > 6 years’ experience in pharmacovigilance and/or data management, clinical care, or clinical or scientific research required

- Health Care Professional or equivalent experience preferred

- Experience and skill with medical writing an advantage

COMPETENCIES REQUIREMENTS

1. Ability Functional

• Ability to independently solve routine problems related to case processing and surface issues constructively
• Ability to make decisions independently in both routine case processing and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impact
• Ability to discern when additional input is required to effectively address unique and/or complex situations
• Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
• Ability to work independently to accomplish team goals with minimal supervision
• Demonstrated ability to foster teamwork
• Fluency in spoken and written English
• Understanding and ability to use computer technology, management of relational database systems, including extraction of data
• Solid working knowledge of pharmacovigilance concepts
• Solid knowledge of national and international regulations
• Solid understanding of medical terminology

2. Cultural Competencies (Leader Behaviors)

• Sustain Focus on Performance
• Create an Inclusive Environment
• Encourage Open Discussion and Debate
• Manage Change
• Develop People
• Align Across Pfizer

辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球***的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.