北京招聘

ADSA specialist is needed to support safety reports preparation and other PV activities.

- Responsible for day-to-day adverse experience case management within the country(ies) covered by the country operation including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per client’s procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements. 

- Responsible for aggregate safety report submissions in the country(ies) in accordance with Global Safety procedures and health authority requirements. 

- Responsible for the reconciliation of adverse events reports received from other client’s operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable Responsible for the filing, storage and archiving of safety-related data in accordance with client’s policies and local requirements. 

- Serve as the local Deputy Qualified Person for PV (QPPV) / deputy local responsible PV person for the country(ies) when delegated by PV Country Lead. 

- Serve as back-up in the absence of the PV Country Lead to ensure business continuity. 

- Responsible for being compliant with local PV regulations, client policies and procedures and Global Safety procedures at the country level. 

- Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation. 

- Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection. Identify and communicate potential safety issues to PV Country Lead. Assist in the delivery of training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors / business partners in the country(ies) within scope. 

- Complete and document required PV training within the required timelines. Perform other activities as requested by the PV Country Lead.

Other Responsibilities:

-Responsible for safety reports preparation and safety data summary; 

-Provide support for PV physician and scientist as needed.

-The double check after AI(机器人) translates Safety reports.

-Document filing and checking.

任职要求：

?Bachelor degree in medical or pharmaceutical sciences required.
?1 year working experience on pharmacovigilance area in pharmaceutical company.
?Fluent Mandarin and English in reading and writing. Written English must be excellent.
?Familiar with all requirements on safety monitoring, be able to ensure the safety compliance
?Collaborative cross-functional working relationships with internal stakeholders
?Understands principles and conception of ICH pharmacovigilance guidelines
?Demonstrates professional and culturally appropriate behavior when dealing with others
?Demonstrates effective project management skills
?Recognizes the need to align relevant information and stakeholder opinions before making decisions that impact results

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