商丘招聘

Job content (purpose of the job)
Key areas of responsibility:
Coordinate daily work and report product safety information and customer complaints comply with SOPs and regulation.
Provide expert advice concerning safety to internal and external customers.

Main job tasks:
Coordinate daily work and report product safety information and customer complaints comply with SOPs and regulation. :
Reporting safety medical information from all sources into the CCGlow, Argus and authority’s reporting system according to SOP & requirements.
Perform accurate and consistent coding using MedDRA of all adverse events reported to NN.
Perform correct medial evaluation of safety information according to requirement.
Communicate with complaint contact person ensure all safety information to be collected for evaluation.
Perform safety surveillance of all NN products and competitor and ensure accurate information to be delivered to relevant department.
Report PSUR/annual safety report according to authority requirements.
Provide expert safety support:
Provide expert safety suggestion for enquiry received from internal and external customers.
Review and ensure accurate of safety part of protocol/ICTR/RMP/labelling or other required documents.
Review and ensure accurate monthly lining list of SUSAR.
Train new NN CRA/investigator on reporting safety information.
Other individual assignments:
None.

Qualifications:
(minimum requirements)
Good communication and problem solving skills.
Advanced knowledge on safety of therapy area and pharmacovigilance regulation.
Fluency in both written & spoken English.
Education:
Bachelor degree or above of clinical medicine.
Professional experience:
Experience of clinical doctor is preferred.
Min 2 years in pharmacovigliance function.
Min 1 year in clinical research. .

Supplementary job description:
Degree of independent decisions:
Authority to decide and act on decisions that impact on handling customer complaint and safety reporting; roughly 30% of independent decisions can be made in this position.
For completed case, such as crisis cases, positional recall cases, roughly 70% of decisions need to be ratified by product safety manger.
Level of innovation:
Completed work by directly following SOPs and regulations..
Main stakeholders:
Internal:Sales, commercial, marketing, medical, finance Department; HQs(Global Safety), NNTP
External: Government or Health Authorities, Customers (Doctors/Patients), CRO
Degree of influence on departmental / function / NN results:
Minor influence on drug safety function results.
Directly influence internal NN staff to handling safety information in compliance.
Communication / Interaction with others internally or externally:
Daily communicate with internal NN staffs (focusing on staffs from sale, marketing, and medical department etc.) and ensure them to understand and follow NN requirement on safety reporting.
Continuously intercommunicate with HQs and ensure HQs to understand NN local regulation requirement.
Describe the scope of the job in terms of working away from the home country :
None

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