Job Purpose ·Prepares (from technical perspective) documents for further processing, review, expediting to be performed by CPO DS&E/PVO.·Ensure technical compliance of  documents with technical guidelines·Support the DS&E/PVO team in their document management duties e.g., formatting documents, QC of documents, archiving·To support management of DS&E/PVO operational processes at Country Pharma Organization (CPO) in ensuring compliance with Client company global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of Client company marketed and investigational productsMajor Accountabilities 1.Prepares the respective submission documents to Health Authorities2.Supervision of proper flow of confirmations of receipt of documentation sent to the Health Authorities.3.Preparation and everyday distribution of respective DS&E documents externally.4.Participation in the verification process of data correctness in the global safety database.5.Verification of correctness and compliance of documentation sent to CPO DS&E Department:·Internal documents translation·Verification if a document sent to DS&E grant the safety requirements of the internal materials as described in respective Client company procedures6.Preparation of the CPO DS&E training materials (incl. confirmations) and logistic organization of these trainings·Editing (where required and as per request from CPO DS&E Member) training materials·Preparation of confirmations, certificates, printing of training materials for participants7.Archiving all safety documentation as per respective policies, guidance and procedures.8.Verification and update of respective CPO DS&E archiving system (incl. review, update, management)9.Manage collection, processing, documentation, reporting and follow-up of all serious adverse events (SAE) reports for all Client company products from clinical trials, post-marketing studies (PMS), registries, and all adverse events from commercial, sales and marketing programs and all Spontaneous Reports (SR).10.Transcribe, translate and enter data of all Serious Adverse Events (from Clinical Trials, post-marketing studies (PMS), registries)  and all adverse events (from commercial, sales and marketing programs and all Spontaneous Reports) from source documents onto safety systems (e.g. Argus Affiliate,  etc) accurately and consistently with emphasis on timeliness and quality.11.Record and track receipts, submissions and distributions of SAEs, SRs, Investigator Notifications (IN)/Suspected Unexpected Serious Adverse Reaction (SUSAR), Periodic Safety Report Updates (PSUR) and Development Safety Update Report (DSUR).12.Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or clinical operations.13.Work with other local/global PVO associates to ensure accurate evaluation of safety data.14.Interact and exchange relevant safety information with LHA, PVO associates, other functional groups and third party contractor, if applicable.15.Support in developing, updating and implementing local procedures to ensure compliance with PVO global procedures and national requirements.16.Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.17.Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries and quality related complaints.Key Performance Indicators   ·Completeness and correctness of the data received and sent out in respective tracking tools/systems·Timely preparation of dispatch·Timely introduction of the respective data into the system/tracking tool·Timely and quality of prepared documentation, training materials·Completeness, clarity and compliance of the archived DS&E documentation with global and local Client company standards·CPO AE reporting compliance·Results of audits/inspections·Customer feedback

职位类别： 生物工程/生物制药

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