南京招聘

Manage collecting, processing, documenting, transmitting, CA declaring and followingup of all PV case in marketed environment including: Spontaneous reports, literature report, post-marketing study, registries, marketing research, etc.

？ Ensure accurate and consistent transcription, translations and data entry of all PV information for marketed products from source documents into local safety systems (LAM) with emphasis on timeliness and quality.

？ Timely report PSUR and overseas SADR to CA in line with Chinese regulation

？ Conduct medical literature screening on a monthly basis to detect PV case associated with products, recording and tracking the results. Handle with the PV information according to internal procedures and local regulations, if applicable.

？ Perform monthly reconciliation with other departments (e.g. Medical Information, Anti-counterfeit, Quality Assurance, Customer complaint Centre and third party contractor, if applicable) for potential AEs resulting from medical inquiries and quality related complaints.

？ Perform monthly reconciliation with PEX TS to ensure all local AEs are accurately collected into safety database (ARGUS). Coordinate with PEX TS to ensure accurate evaluation of safety signal.

？ Conduct initial and continuous PV training, including training course by e-learning to below staffs in accordance with internal PV training procedure?

All personnel in China;?

3RD party if applicable?

CRA, PM,CRO?

Investigators

？ Pay close attention to relevant Chinese regulation, guidance and instruction; watch global PV policy; and timely update local PV policy if necessary.

？ Manage expedited and periodic safety report arising in clinical trial for developing drugs:? report domestic ERIN to HQ and CFDA/MOH; report domestic SUSAR to Hongkong DOH;? report foreign SUSAR to CFDA/investigator on a monthly basis;? distribute domestic SAE line listing to investigator on a monthly basis;? report periodic safety report to Hong Kong DOHOther safety report as requested by internal SOP, OPM, local regulation or guidance.

？ Timely manage tracking and archiving of all PV activities including: receipts,processing, reporting and follow-up of all PV reports, either for marketed or developing product.

？ Provide safety support to business department:? Preparing safety summary for product renewal? Reviewing the safety part of the product package insert? review safety part of protocol ？

Qualifications & Experiences Required Knowledge/ Academic Qualification:

A bachelor degree in clinical medical, pharmacy, health discipline or life sciences is minimum

Skills:Fluent in both written and spoken English

Computer literacy Experience:· >3 years pharmaceutical or clinical research experience, pharmacovigilance experience preferred

Knowledge of Chinese regulations for pharmacovigilance？ Knowledge of pharmacological and medical terminology.

Competency： Capability of working with large volume of data, good at time management, Excellent communications, interpersonal skills

Please send CV to jenny.zhang@docsglobal.com

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.