上海招聘

GENERAL DESCRIPTION AND RESPONSIBILITIES

The Pharmacovigilance Specialist will perform various tasks in support of clinical research including reviewing adverse events, preparation of case reports, analyses, and clinical site support.

o Responsible for reporting, maintaining safety/pharmacovigilance database, compliance & distribution of individual case/SAE reports for the region.
o Responsible for and ensures the receipt of and distribution of individual case safety reports from all sources in a timely manner.
o Responsible for and ensures the reconciliation of the safety database.
o Maintains current knowledge of regulations governing the processing and reporting of safety data, SOP's and work instructions in the region.

This job description does not list all duties of the job. Employees may be asked by supervisors or management to perform other duties.



MINIMUM REQUIREMENTS

o Medical Degree, Registered Nurse or PhD healthcare degree required
o Minimum 1-2 years related work experience
o Knowledge of Clinical Data Management, and Good Clinical Practices.
o Familiarity with pharmaceutical industry of pharmacovigilance is preferred
o Practices and experience with medical writing is a plus.
o Excellent oral, written, presentation and computer skills. Experience with Serious Adverse Events is a plus.
o Good knowledge of medical terminology
o Working knowledge of relevant regulations and guidance documents governing both safety reporting and processing for clinical trial and post-marketing environment
o Strong organizational skills, detail oriented, ability to adapt in a fast paced constantly changing environment
o Clear, effective written and verbal communication skills
o Ability to work under pressure in order to meet tight deadlines

* ABOUT US

EPS INTERNATIONAL CO., LTD (EPS INTERNATIONAL), a clinical service provider established by a reputable leading full service Japanese contract research organization – EPS Co. Ltd (EPS), commences its operations in 1999 to provide an integrated, seamless and optimal drug development platform through synergizing EPS’s long-established clinical resources and operations in Asia region to best support increasing outsourcing needs in the research, development and commercialization of pharmaceutical products and medical devices initiated by global and Japanese companies worldwide.
 
We have strong presence in Asia and are fast expanding our footprints in the Pacific, Europe and US.
 
Website www.epsgr.com
 
 
* COMPANY VALUES

In line with EPS’s corporate visions, EPS INTERNATIONAL aims to be an “Ever Progressing System” by continuously delivering quality clinical services, providing efficient and effective turn-key solutions for our Clients’ products development needs in Asia region.
 
 
* COMPANY SUCCESS
 
EPS INTERNATIONAL leverages and applies EPS’s values with many years of combined experiences as an added value to our Clients’ programs ranging from research, development to commercialization in key Asian countries. Lead by a great team of professionals with in-depth experiences and relationships supported by regional clinical networks, key opinion leaders and good performance sites, EPS INTERNATIONAL is the preferred outsourcing partner in Asia.

 
One of the large CRO in Japan and listed on Tokyo Nikki Stock Exchange. We are profitable and have strong and stable financial support from EPS Group.


A full service provider from Bioanalytics (Phase I) to Phase IV to Central lab, patient recruitment services, resource solution to meet clients one-stop shop needs


Strong language capabilities within the team - Japanese, Chinese & English. Known as the best Japanese study CRO service provider.

 
Our Data Management Group has a strong brand and reputation in the industry

 
Comparatively large clinical operation team with wide therapeutic area experience that spans over Asia.