青岛招聘

Responsible for the safety assessment activities of assigned products
under the supervision of Global PVRM Therapeutic Area Head, including:
? Monitor the benefit risk profile of assigned portfolio in an ongoing fashion and in accordance
with BPH and GPV processes
o Lead the PV risk management processes including chairing Safety Management Teams
o Identify, prioritize and analyze clinical safety signals
o Perform ongoing review of emerging safety data from various sources including single case reports, PTCs and published literature and reports from partner functions
o Work with the Systems and Operations teams to develop and continuously maintain and improve effective systems to ensure single cases (inc PTCs and other relevant reports) fulfill the requirements for signal detection and aggregate report compilation through targeted training
o Ensure appropriate clinical safety risk communication and escalation within BPH to GPV Management and QPPV and BPH Safety Committees including SRC, GSC, PET and GLC
o Produce high quality aggregate reports and responses to regulatory queries
o Ensure adequate labeling of safety related information
? Ensure effective and timely delivery of:
o Aggregate reports including PSUR/PBRERs, DSURs, DRMPs and RMPs (core and EU)
o Benefit Risk Statements
o Safety section of DCSI and relevant Position paper and Justification documents
o Answers to assigned safety relevant HAs requests and complex A2Qs
o Safety relevant communications such as DHCP letters and company statements.
? Liaise with internal and external experts /KOLs to obtain specialized medical expertise as
appropriate
? Provide high quality and consistent input to development teams and product teams to support clinical development and life cycle management
? Provide medical safety oversight of clinical study data in the context of the medical review
process for clinical studies
? Interact with license partners to support the Global license officer in the preparation and
maintenance of PV agreements
? Perform effective due diligence activities within the assigned TA
? Support GPV-RM TA Head in strategic decision making
任职要求：
? MD degree or equivalent (eg, DO or MB) required.
? Two years or more of clinical experience as well as at least 2 years of pharmacovigilance experience, or overall equivalent experience profile.
? Specialty certification preferred.
Competencies:
? Appropriate experience with Regulatory Agency and KOL interactions
? Good knowledge of pharmacovigilance relevant regulations and BPH standards.
? Proven evidence of effective delivery of high quality safety relevant documents.
? Knowledge of relevant concepts in data management and systems pharmacoepidemiology and statistics
? Fluent English

PPC佳生集团（PPC Group）是一家成立于1997年的临床CRO公司。总部设立于上海，并分别在台北，徐州，北京，南京，首尔及东京设立了分部及分公司。
     自成立以来我们始终致力于为国内外制药企业及生物技术公司提供专业的临床研究服务及生物样本分析服务。至今，PPC佳生已经完成了超过3000项早期临床试验项目及超过500项II期至IV期临床试验项目，其中涉及24个主要研究领域。
     另外，PPC佳生的I期临床中心及生物分析实验室也分别通过了美国FDA,中国NMPA,台湾TFDA,日本PMDA,欧盟EMA及马来西亚NPRA等的核查。
     2012年，PPC佳生在台北（MacKay Memorial Hospital）建立了***家专属I期临床研究中心；2017年初与徐州医科大学合作共同建立了徐州医科大学附属医院I期临床研究中心；2018年，PPC佳生又分别与徐州市中心医院，湖北省鄂东医疗集团黄石市中心医院以及上海市浦东新区人民医院共同建立并开设了三家专属的I期临床研究中心。截至目前，PPC佳生已有5家自主运营的I期临床中心。