东莞招聘

工作职责:

Position Purpose

Oversees all aspects of creating, maintaining and implementing a comprehensive, dynamic and resource efficient calendar of safety deliverables.  This includes, but is not limited to IND ARs, DSURs, PADERs, PAERs, PSURs, SUSAR LLs and applicable ad hoc safety queries.  This position negotiates safety submission commitments with Pfizer Country Offices and/or Regulatory, ensuring compliance needs are met while balancing resource effort to create submission documents; interacts with requestors to resolve ad hoc report scheduling; and proposes assignments.

Primary Responsibilities

Creates and maintains the comprehensive calendar of safety deliverables.

Enters and assigns routine, non-routine and ad hoc safety deliverables.

Negotiates with appropriate groups (e.g. PCOs) to ensure that aggregate report commitments are met, while minimizing, the number of individual reports required, when possible, as well as developing schedules for new aggregate report types as required by regulations.

Participates in appropriate governance and policy meetings/groups.Is empowered to make independent decisions affecting the operations of the group.

Acts as subject matter expert on aggregate reports scheduling and represents this role on various teams and taskforces.

Acts as business subject matter expert for systems used for aggregate reports calendar (DocFlow) and the RMP assignment (Compass) and participates in various technology forums.

Designs, implements, and reports relevant aggregate reporting metrics.

Supports Audit/inspection requests.

Maintains License Partner aggregate report requests mailbox.

Technical Skill Requirements

Demonstrated ability to lead/manage and bring projects to successful completion while simultaneously juggling multiple projects and processes that span globally.

General knowledge/understanding of technologies that can support Pfizer’s safety submission work.Ability to adequately evaluate and leverage Pfizer’s system into improved business processes to support business requirements.

Comprehensive working knowledge of requirement gathering, database design, and reporting.

Knowledge of clinical development and/or regulatory submission processes and requirements.Knowledge of safety submission work, e.g. aggregate reporting requirements and processes.

Effective oral and written communication.Demonstrated ability to design, develop and deliver effective presentations to key business units.

任职资格:

Qualifications (i.e., preferred education, experience, attributes)

Scientific/technical academic background or equivalent, ideally with experience in the pharmaceutical industry, regulatory agency, or related field.  Understanding of clinical trials and drug development and comprehensive knowledge of the regulatory environment.

Associate Manager

Basic knowledge of safety and global regulatory reporting regulations and guidelines.

Strong project management skills with appropriate follow-through

Develop and run relevant aggregate reporting metrics and/or reports

Preforms scheduling lead responsibilities with guidance

Manager

Strong understanding of safety and global regulatory reporting regulations and guidelines.

Comprehensive working knowledge and understanding of IT requirement gathering, database structure, design and reporting tools.

Demonstrated ability to manage projects successfully, with minimal guidance.

Participates in appropriate governance and policy meetings/groups

Associate Director

Strong interpersonal skills with demonstrated ability to build relationships and influence outcomes.

Extensive understanding of regulatory/safety regulations and guidelines and can independently answer complex scheduling queries appropriately.

Strong project management and issue resolution skills.

Able to deliver effective presentations to key business units, as needed.

Director

Leads projects/discussions.

Proven record in leadership, delivering business solutions and customer service

Recommends regulatory reporting courses of action to management, as appropriate.

Acknowledged a subject matter expert.

#LI-PFE    

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.