长沙招聘

Essential/Primary Duties, Functions and Responsibilities （工作内容）

Adverse Event Case Management Responsibilities:

• Ensure that all safety reports received from any source (clinical trials and post-marketing) are triaged, scheduled, processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures.
• Monitorall cases in the Workflow to manage departmental workload and to ensure adherence processing timelines.
• Ensure appropriateness of MedDRA and WHO-DD coding performed by Drug Safety staff.
• Coordinate the submission of expedited and non-expedited safety reports to regulatory authorities, clients, EC, investigators, and partner companies.
• Liaise with assigned Physicians in Drug Safety, Clinical operation, and/or Medical Affair to ensure that appropriate medical review and assessment is provided for assigned case reports.
• Communicate with clients, collaborative sponsors regarding the evaluation and processing of case reports.

Additional Safety Management Responsibilities:

• Oversee the set-up of new safety projects, including development of study-specific Safety Management Plans and set-up of safety systems.
• Participate in the planning and preparation of the adverse events section of protocols with Medical Safety Officer for clinical studies, review of paper and/or electronic CRFs, and investigator meeting presentations.
• Participate in the development and management of Data Monitoring Committees, including development of DMC Charters and QA/QC of required line-listings and aggregate summaries of the safety data.
• Oversee the reconciliation of safety data with groups external to company Drug Safety (e.g., Data Management staff for clinical studies, Drug Safety personnel from partner companies/clients, etc.)
• Participate in the preparation of ASURs, DSURs, IND Annual Reports, PSURs, RMP, and other global periodic safety reports.
• Assists MSO in the development and review of appropriate safety sections of IBs, CSRs, ISS, NDAs.
• Monitor the process for MedDRA , WHO-DD and other medical dictionary coding of clinical trial and postmarketing data.
• Review aggregate safety data from the clinical database in support of Data Monitoring Committee meetings, interim analyses or final database lock.
• Provide support/training in all aspects of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post-authorization studies, spontaneous reporting, and literature.
• Other duties as assigned

Departmental and Line Management Responsibilities:

• Assist in monitoring industry best practices, and changes in global safety regulations and guidelines for marketed and investigational products, and recommend changes and upgrades to existing departmental policies, SOPs and systems.
• Develop departmental or cross functional SOPs, policies and working guidelines, as assigned.
• Effectively manage utilization of departmental personnel to ensure planned activities are adequately resourced, agreed upon timelines are met, and that colleagues are fully engaged in supporting the business.
• Ensure that new hires are suitably qualified and that personnel are developed to ensure that their drug safety skills are in line with the business need, and that staff have a strong awareness and understanding of the appropriate worldwide safety regulations.
• Assist in development and maintenance of the Drug Safety departmental budget
• Train appropriate company personnel and external groups in drug safety principles, SOPs and policies.
• Participate in the maintenance of thesafety database, including participation in validation and implementation activities for system upgrades and maintenance of the safety database user manual.
• Contact immediately management if a regulatory agency or client has requested an inspection, or if there are any serious non-compliance observations within the Drug Safety department.

Management of Direct Reports:

• Mentor, train and supervise staff at a functional level
• Ensure each new direct report is on-boarded and trained per company and departmental guidelines and SOPs
• Review and authorize activities to assess the workload of direct reports.
• Identify any performance issues and ensure an appropriate and timely performance improvement plan is undertaken.
• Identify training needs of direct reports and develop training plans to address those needs.

Requirements （任职资格）

Work Experience:

• Minimum 3 – 5 years of Pharmacovigilance / Drug Safety experience or equivalent required. Both pre-approval and post-marketing experience in a global environment highly desired.
• Preferably 2-5 year supervisory experience desired

Functional/Technical Knowledge & Skills:

• Expert knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments.
• Extensive knowledge of medical terminology and principles of clinical assessment of adverse events in the pharmaceutical industry.
• Expertise in MedDRA dictionary with relevance to adverse event coding.
• Extensive experience with software-based drug safety systems required.
• Strong computer skills (MS Office)
• Strong knowledge of pharmaceutical/biotech industry and the overall drug development process.

Education/Training:

• At a minimum, Bachelor’s level degree in medicine, pharmacy, life science, or nursing. Master or Doctor Degree is plus.

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