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更新于 6月4日

Sr. Mgr, Safety Risk Lead - MD

4-6.5萬(wàn)
  • 武漢洪山區(qū)
  • 1-3年
  • 碩士
  • 全職
  • 招1人

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  • 團(tuán)隊(duì)執(zhí)行強(qiáng)
  • 工作環(huán)境好
  • 人際關(guān)系好
  • 氛圍活躍
  • 實(shí)力大公司

職位描述

藥企
ROLE SUMMARY As an experienced medical safety professional, the role requires one to exercise the highest quality of medical judgment to inform a robust understanding of the benefit-risk profile across Pfizer’s portfolio and to advocate for patient safety from first-in-human and throughout a product’s lifecycle. The SSRM Safety Risk Lead is accountable for the global medical safety management of Pfizer products and performs proactive signal detection and evaluation, and risk assessment/minimization to ensure Pfizer products are safe for patients. He/she will provide organizational leadership within SSRM and within Pfizer, including: ● Performs proactive safety surveillance and risk management to effect product safety signal detection & evaluation, risk assessment and safety risk minimization ● Works with other Pfizer functions engaged in benefit-risk management (Regulatory Affairs, Quality, CMO, Corporate Audit, etc) to enable one medical voice Articulates clear and informed medical judgement to enable sound business decisions and to enable productive engagement with health authorities. ROLE RESPONSIBILITIES ● Act as a point of contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing WWS position(s) on safety ● Chairs RMCs and Core Working Groups for his/her assigned products with oversight ● Represents Pfizer WWS at internal (e.g. governance and business unit disease area leadership teams) and external forums (e.g. regulatory authority and business partner interactions) as agreed with Manager ● Evaluates safety data of any source with oversight, identifies and analyzes safety signals, and presents medical evaluation of safety signals and benefit-risk assessments to the appropriate forums ● Provides disease area specific pharmacovigilance expertise, and applies this to various business unit products assigned to him/her ● Assists with preparation of basic action plans to address risk and benefit-risk issues, often requiring cross-functional activity to address safety issues and risk minimization plans ● Prepares and contributes to written safety assessments and benefit-risk evaluations ● Reviews and approves, as appropriate, safety documents including those pertaining to the B-R profile of Pfizer’s products ● Ensures consistency of safety risk messaging for a particular product or class of products, across multiple indications/BUs. Represents SSRM on due diligence activities ● Identifies opportunities for consistency and standards for safety surveillance and risk management processes ● Innovates, champions and implements novel approaches to safety surveillance and risk management across Pfizer’s portfolio of products: engages in continuous improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements ● Engages in inspection readiness support including provision of data to project managers for metrics and activity tracking ● Develops a culture of courage, excellence, equity and joy within the team including regular communications, coaching, and mentoring of the team as required. ● Makes decisions based on clinical experience Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities QUALIFICATIONS BASIC QUALIFICATIONS Professional Experience & Educational Requirements ● Minimum 2 Years of medical experience PREFFERED QUALIFICATIONS ● Disease area-specific knowledge preferred ● Awareness of safety risk management internal and external environment, including applicable regulations and guidances ● Knowledge of drug development process and post-marketing experience, including an understanding of safety context across the drug lifecycle ● Ability to influence internal and external stakeholders ● Ability to act independently, seeking guidance as appropriate; recognizes other colleagues’ areas of expertise and engages them effectively to achieve team objectives ● Demonstrated leadership in day-to-day activities, including strong interpersonal and collaborative skills Technical Skills Requirements ● Understanding of aggregate safety data and signal assessment methodology, and ability to perform benefit-risk assessments ● Ability to perform safety data review, safety data assessment, Clinical safety signal identification, risk identification and risk management ● Understanding of the scientific basis for therapies and drug-induced diseases ● Ability to lead a cross functional team and lead through example, commitment and enthusiasm in a matrixed environment with minimal oversight ● Strong scientific and medical knowledge, including fluency in the medical literature ● Ability to integrate data to support benefit/risk decision-making ● Understanding of statistics and analytical tools ● Knowledge of global safety/regulatory issues and concerns as they relate to the business or clinical research-based compound development ● Effective verbal and written communication skills Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Medical #LI-PFE

工作地點(diǎn)

洪山區(qū)輝瑞(武漢)研究開(kāi)發(fā)有限公司

職位發(fā)布者

劉一飛/人事經(jīng)理

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輝瑞公司(Pfizer Inc.)創(chuàng)建于1849年,總部位于美國(guó)紐約,是一家以科學(xué)為基礎(chǔ)的、創(chuàng)新的、以患者為先的生物制藥公司。輝瑞的使命是“為患者帶來(lái)改變其生活的突破創(chuàng)新”。在輝瑞,我們通過(guò)科學(xué)和全球資源為人們提供治療方案,以延長(zhǎng)其生命,顯著改善其生活。在醫(yī)療衛(wèi)生產(chǎn)品的探索、研發(fā)和生產(chǎn)過(guò)程中,輝瑞始終致力于奉行嚴(yán)格的質(zhì)量、安全和價(jià)值標(biāo)準(zhǔn)。我們?cè)谌虻漠a(chǎn)品組合包括創(chuàng)新藥品和疫苗。每天,輝瑞在發(fā)達(dá)和新興市場(chǎng)的員工都在推進(jìn)人類(lèi)健康,推動(dòng)疾病的預(yù)防、治療和治愈,以應(yīng)對(duì)挑戰(zhàn)我們這個(gè)時(shí)代的頑疾。輝瑞還與醫(yī)療衛(wèi)生服務(wù)方、政府和社區(qū)合作,支持并促進(jìn)世界各地的人們能夠獲得更為可靠和可承付的醫(yī)療衛(wèi)生服務(wù)。這與輝瑞作為一家全球卓越的創(chuàng)新生物制藥公司的責(zé)任是一致的。170余年來(lái),輝瑞一直致力于為所有依賴(lài)我們的人帶來(lái)改變。輝瑞于1989年進(jìn)入中國(guó)市場(chǎng)。扎根中國(guó)30余年,輝瑞已成為在華主要的外資制藥公司之一。2021年是輝瑞新征程的開(kāi)始。迄今已有170余年歷史的輝瑞正在邁入全新時(shí)代,成為一家以科學(xué)為基礎(chǔ)的、創(chuàng)新的、以患者為先的生物制藥公司。目前輝瑞在中國(guó)業(yè)務(wù)覆蓋全國(guó)300余個(gè)城市,累計(jì)投資超過(guò)15億美元,并設(shè)立了1家先進(jìn)的生產(chǎn)設(shè)施,2個(gè)研發(fā)中心(分別位于上海張江高科技園區(qū)和武漢光谷),在華有近7,000名員工分布于業(yè)務(wù)、研發(fā)和生產(chǎn)等領(lǐng)域。輝瑞在華上市了五大領(lǐng)域的高品質(zhì)創(chuàng)新產(chǎn)品,包括腫瘤、疫苗、抗感染、炎癥與免疫、罕見(jiàn)病等多個(gè)領(lǐng)域的處方藥和疫苗,強(qiáng)大完善的產(chǎn)品線旨在滿足生命各階段的健康需求。
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