长沙招聘

Position Purpose
? SRLs perform proactive Safety Surveillance (SS) and Risk Management (RM) to effect product safety signal detection & evaluation, risk assessment and safety risk minimization.
? Safety Risk Leads (SRL) in SSRM may be assigned as the product “safety-management-team” (e.g. Risk Management Committee) Chairs and Asset (Product) Team safety representatives, flexibly supporting all BU/RUs. SRLs may act as a Point of Contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing SEPGR position(s) on safety.

Primary Responsibilities
Performs proactive Safety Surveillance (SS) and Risk Management (RM) to effect product safety signal detection, risk assessment and safety risk minimization.

Colleague capability (see separately available SRL capabilities and responsibilities continuum) will drive Nature and Complexity of Assigned Responsibilities and Activities:

? Safety Risk Leads (SRL) in SSRM may be assigned as the product “safety-management-team” (e.g. Risk Management Committee) Chairs and Asset (Product) Team safety representatives, flexibly supporting all BU/RUs. They will collaborate closely with the relevant SEPGR Safety Strategy Business Unit/Research Unit Leads to support the appropriate BU safety strategies.
o The SRL obtains guidance from the relevant SEPGR Safety Strategy Business Unit/Research Unit Leads to meet the BU/RU Safety Strategy goals.
o SRLs may be assigned to act as a Safety Point of Contact to the Asset Teams, ensuring a unified communication on safety matters for SEPGR/WSRO.
? Providing and accumulating DA-specific pharmacovigilance expertise, and applying this to various BUs’ products assigned to the SRL operating from a SSRM DA-Cluster. Each SSRM DA-Cluster functions as a “Centre of Excellence”.
? Performing frequent proactive Holistic Safety Review for products, across the span of relevant available safety data information. Reviews are incremental, cumulative and aggregate, to include the body of safety information available from SEPGR/WSRO and elsewhere (e.g. clinical, epidemiology, spontaneous, literature & regulatory cases, other scientific data).
? Ensuring Consistency of Safety Risk Messaging for a particular product or class of products, across multiple indications/BUs within the many safety reports and communications for that product. Providing suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements and overall risk messaging of the safety profile to WSRO Authors.
? Performing ad hoc special scholarly SS & RM activities, rapidly, to meet specific needs in the BUs, such as RRT deliverables/emerging safety issue white papers/product Due Diligence Assessments.
? Identifying opportunities for Consistency and Standards for SS & RM approaches and processes within a DA-Cluster and across BUs, and supporting the piloting and implementation of such.
? Innovating, championing and implementing Novel Approaches to SS & RM across BUs: engagement in Continuous Improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements.
? Platform for additional Centers of Excellence (e.g. Vaccines, Safety Advisory Councils, Contributions to or coordination of Other Pan-BU/RU activities).]
? Engagement in inspection readiness and support. Provision of data to project managers for metrics and activity tracking.
? Further;
o Providing SS & RM support for a particular product, across the product’s multiple use in different BUs
o Providing SS & RM support for a particular product in a BU, within and across the product’s multiple indications in a BU
o Leveraging DA focused expertise flexibly into all BUs, and deployment to Due Diligence in-licensing assessments
o Focuses intra- and inter- DA-Cluster sharing of information between related areas (e.g. safety knowledge of Pain vs Inflammation co-prescribing)
o Enables “matrix assignment” from within SSRM to supporting Safety Strategy BU Leads
May work across more than one SSRM DA or DA-Cluster as appropriate to business need. The SRL may support product teams locally or globally (remote).

May be assigned to chair/lead/support various Safety Management Teams (e.g. RMC and RMC CWGs etc.), on one or more products or group of products, for one or more Business Units.
(Note: “BU” used herein = BU/RU).

Technical Skill Requirements
Colleague capability (see separately available SRL capabilities and responsibilities continuum) will drive Nature and Complexity of Assigned Responsibilities and Activities.

Skills, (plus knowledge, experience and ability in):

? Safety data review, Safety data assessment, Clinical Safety signal identification, risk identification and risk management. Understands aggregate safety data and signal assessment, and performs benefit-risk assessments. From a medical perspective, independently evaluates safety data, identifies and independently analyzes safety signals, and presents the medical evaluation of safety signals to the appropriate forums.
? Matrix safety team leadership
? Understanding of the scientific basis for therapies and drug-induced diseases. Effective interactions with key external subject matter experts including regulatory authorities
? Strong Matrix partnering, inclusiveness and collaborative working relationship with SEPGR/WSRO colleagues, including engaging Safety Strategy BU Lead, Epidemiology Leads and other colleagues supplying sources of safety information. Actively engages WSRO & SEPGR colleagues in RMCs and Asset teams as needed.
? Effectively communicating resource, timeline and other issues that have e.g. regulatory impact, to the Safety Strategy BU Lead(s).
? Assisting with communication and knowledge transfer within and between SSRM DA Clusters, and across project/product teams.
? Working effectively when co-located with, AND when remote from, product teams/leaders/managers.
? Championing high quality SSRM deliverables, and innovation.
? See also experience/attributes below


Qualifications (i.e., preferred education, experience, attributes)
? Colleague capability (see separately available SRL capabilities and responsibilities continuum) will drive Nature and Complexity of Assigned Responsibilities and Activities.
? MD (physician) or DVM (veterinarian). Others: PharmD (pharmacist); PhD; MSc; or equivalents. Appropriate Pharma experience in SS & RM.
? DA-specific knowledge is preferred.
? Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidances.
? Displays a sound understanding of the scientific basis for therapies and drug-induced diseases. Comprehensive knowledge of drug development process.
? Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle.
? Able to act independently, seeking guidance as appropriate. Demonstrates leadership in day-to- day activities and collaborative skills.
? Can handle more than one complex project simultaneously, prioritizing well and recognizing key issues.
? Ability in, and track record of, working effectively in an advanced matrix structure, including matrix team leadership/representation preferred.
? Recognizes other colleagues’ areas of expertise and utilizes them effectively to achieve team objectives. Runs effective meetings, including all colleagues’ diverse opinions and bringing group to consensus. Next steps and actions are clear.
? Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
? Relevant knowledge of Pharmaceutical Company organizational structure, policies, and practices, as applicable to safety Risk Management.
? See also Technical Skill Requirements section.

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。