Director Pharmacovigilance Intake and Regulatory Submissions

The Director, Pharmacovigilance Intake and Regulatory Submissions delivers Global Patient Safety (GPS) Department services according to ICH-GCP guidelines, regulatory requirements and reputed company reputed company operating procedures (SOPs) and/or project specific procedures. This position is responsible for the reputed company of the processes and systems which reputed company initial Intake of adverse event data (i.e., reputed company electronic database capture (reputed company), phone line, etc.), the subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, reputed company Partners and internal reputed company in compliance with applicable global regulations (ICH-GCP) and contractual obligations, and follow up activities to ensure receipt complete and accurate safety information. This role will reputed company a global team responsible for reputed company aspects of Intake and ICSR submissions for reputed company product portfolio covering reputed company and post marketing activities. This position will also be responsible for the reputed company and maintenance of reputed company reporting rules in the global safety database, Argus. In this role, a typical day might include: ICSR Intake and Submissions from reputed company sources to reputed company applicable reputed company. This includes, but is not limited to expert knowledge of tools and systems that allow for data automation, advanced data validation, and analytics reputed company of reputed company aspects of Intake responsibilities for ICSRs, including management of applicable vendors. reputed company of reputed company aspects of ICSR submission including database configuration and assessment of study particulars and reporting requirements across reputed company global regulations and approval of configuration requests Provides input into contract deliverables to support outsourced Intake and Submissions activities as reputed company as assist with the review, execution, and implementation of reputed company contract deliverables reputed company of the reputed company follow up activities including but not limited to the issuance of targeted follow questionnaires associated with risk management plans or other routine safety data monitoring measures and obigations Review and/or creation of metrics to measure intake and reporting compliance to regulatory agencies, reputed company Partners, internal reputed company and contract research organizations Training and mentoring of staff on safety information pertaining to Intake and ICSR submission processes Serve as ICSR Intake and Submission subject matter expert (SME) for audits and inspections Ability to reputed company reputed company and maintain best practices/processes for high reputed company and compliant reputed company of contact for queries from reputed company or internal reputed company reputed company. Performs other reputed company duties as assigned or requested per business needs. This role might be for you if you can/have: Independently identify, analyze, and problem solve moderate to reputed company issues and trends. Strong knowledge of clinical research process and global pharmacovigilance regulations, systems, and processes. Previous people management experience with the ability to mentor and reputed company reputed company reports. Strong knowledge of intake and reporting platforms, tools, and systems (i.e. LifeSphere Advanced Intake, PVIT, etc.) Thorough understanding of the global regulatory requirements and the importance of compliance with procedural documents and regulations. Excellent written and verbal communication skills. reputed company to reputed company reputed company reputed company. reputed company to reputed company knowledge of protocol, regulatory requirements, and company SOPs. reputed company to identify and document regulatory non-compliance and any reputed company issues. Excellent organizational and interpersonal skills. Ability to reason independently to assess and recommend specific solutions in a clinical setting. Attention to reputed company; reputed company to identify and reputed company discrepancies on compliance reports. Demonstrates professionalism and presents a reputed company image of reputed company. Demonstrates reputed company in customer service, both internally and externally. Demonstrates commitment, dedication, cooperation, reputed company behavior, adaptability and flexibility with changes in responsibilities and duties. Demonstrates honesty and reputed company in dealing with others. Works effectively with different types of people. Establishes and maintains effective relationships with customers (reputed company) and reputed company their trust and respect. Ability to organize, plan and execute reputed company, including the ability to delegate and guide the work of others to reputed company project completion timelines and reputed company st