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Syneos Health赛纽仕医药是一家全面整合生物制药解决方案的公司，旨在帮助客户加快推出新疗法的速度。我们站在产品研发的角度，战略性地融合临床研发、医学事务和商业能力，以及时应对最新市场变化。 想了解更多关于我们如何缩短从实验室到现实生活的距离，请访问或订阅我们的播客。



JOB SUMMARY

Assists with safety and pharmacovigilance program delivery activities including (but not limited to) all aspects of the collection, processing, and reporting of individual cases safety reports (ICSRs), literature screening and review for safety, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, data management activities which includes cleaning and validation of data (xEVMPD product dictionary, manual recoding of substance/product terms arising from ICSR reports, management of duplicate ICSR cases, quality review of ICSRs, Substances, Products, Organisations and Referentials (SPOR) / Identification of Medicinal Products (IDMP) activities and preparation of expedited and periodic safety reports, while adhering to all data privacy guidelines, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs. The processing of information may include filtering, cleaning, migrating, analyzing, reporting, filing or publication of data and information.

JOB RESPONSIBILITIES

· Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.

· Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.

o Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.

o Enters data into safety database.

o Codes events, medical history, concomitant medications, and tests.

o Compiles complete narrative summaries.

o Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.

o Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.

· Maintains safety tracking for assigned activities.

· Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.

· Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.

· Manual recoding of un-recoded product and substance terms arises from ICSRs.

· Identification and management of duplicate ICSRs.

· Activities related to SPOR / IDMP.

· Quality review of ICSRs.

· Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.

· Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.

· Fosters constructive and professional working relationships with all project team members, internal and external.

· Participates in audits as required/appropriate.

· Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

QUALIFICATION REQUIREMENTS

· Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.

· Safety Database systems and knowledge of medical terminology required.

· Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.

· Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.

· Ability to work independently and in a team environment.

· Good communication and interpersonal skills, both written and spoken.

· Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.

· Detail oriented with a high degree of accuracy and ability to meet deadlines.

About Syneos Health
Syneos Health (Nasdaq:SYNH*) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together, we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to lifeTM visit ****************.

* We expect Syneos Health common shares to trade on the Nasdaq Global Select Market under the new name and new ticker symbol “SYNH” by January 9, 2018. Until then, Syneos Health will continue to be listed under INC Research Holdings, Inc. and the symbol “INCR.”


FOR USE AFTER JANUARY 9
About Syneos Health
Syneos Health (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together, we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to lifeTM visit ****************.