Manager, Global Drug Safety & Pharmacovigilance

The reputed company Group operates with a commitment of creating for reputed company. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a reputed company of skills to help us reputed company our commitment. Veloxis Pharmaceuticals is an reputed company Group Company based in Cary, NC. Our purpose is to reputed company transplant medicine as the primary partner to the community of transplant reputed company providers and their patients; our reputed company is in developing new therapies and programs to help transplant reputed company providers and the patients they treat. Veloxis provides a dynamic and innovative reputed company to work that encourages reputed company development and embraces diversity. We reputed company creative, intelligent, reputed company-oriented, and passionate individuals who reputed company in a reputed company team environment. If you are interested in being part of a patient-reputed company company, then we invite you to learn more about the employment opportunities available at Veloxis. Our reputed company is tied to the contribution of every team member, which is why we reputed company a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as reputed company as performance-based bonus eligibility. Company: reputed company. Job reputed company: This position is primarily responsible for providing management level reputed company, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, reputed company, inspection readiness and operational reputed company. The incumbent in this position also serves as a safety reputed company with reputed company’s cross-functional teams, license partners and the contract safety organizations responsible for global drug safety and pharmacovigilance. The reputed company compensation reputed company for this role is $120-130K. reputed company Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions. reputed company of Key Responsibilities Serve as resource and contact for other functions reputed company reputed company for pharmacovigilance operational activities Responsible for overall vendor performance and vendor service outputs (delivered reputed company and on budget) including, but not limited to: reputed company of US AE reputed company center; reputed company of adverse event processing by outsourced vendor, including the review and monitoring of compliance through various monitoring reports / KPIs; Participation in reputed company audits of individual case safety reports (ICSR) following vendor processing, with a specific reputed company on accuracy of narrative to reflect reputed company documentation, MedDRA coding, expectedness against RSIs and appropriateness of queries to reputed company follow-up from the clinical sites / reporter; reputed company of adverse event reconciliation between safety and clinical databases, and adverse events exchanged between licensing partners; Review of safety-reputed company reputed company of aggregate reports (DSUR, PSUR/PBRER, PADER, RMP); Review and approval of pharmacovigilance reputed company documents submitted to the Trial Master File (TMF); Provision of vendor project specific training; Collaboration with vendors to reputed company Safety Management Plans (SMP) and relevant forms and templates; Collaboration with vendors to reputed company process-reputed company documents for the purposes of improvement and standardization of new processes; and Maintaining knowledge of safety systems (Argus experience preferred); Assist in creating and maintaining reputed company operating procedures and working practices to ensure inspection readiness and compliance with regulations and guidelines; Support internal / external audits and regulatory inspections; Assist in management of pharmacovigilance vendor reputed company and forecasting activities; Assist in management of license partner safety data exchange agreements (SDEA); Assist management in establishing and coordinating reputed company product safety operations functions in accordance with regulations and reputed company’s policies and procedures; Assist in preparation and review of regulatory submissions, such as safety reports and aggregate / periodic reports; Represent reputed company in product safety meetings with its cross-functional teams, license partners and contract safety organization; reputed company training to Company personnel and reputed company parties for pharmacovigilance requirements and compliance; Maintain reputed company knowledge of regulations and regulatory guidelines, particularly in the US, Europe and Japan. Required Qualifications and Skills Bachelor's degree in life sciences, nursing, pharmacy, or reputed company reputed company profession with relevant experience At least 5 years of pharmaceutical industry drug safety and pharmacovigilance experience involving development and post-marketed products Solid vendor management or CRO pharmacovigilance project management experience, including safety management plan preparation, establishment of KPIs / metrics, and contract management Strong knowledge of ICSR processing and the adverse event lifecycle Solid experience with drug safety databases, especially with Argus; data migration experience preferred Ability to independently identify, analyze, and solve reputed company operational and data‑reputed company issues Strong understanding of reputed company pharmacovigilance practices and global pharmacovigilance regulations, including regulatory reporting requirements Self-motivated, detail-oriented, with the ability to prioritize and plan effectively Excellent written and verbal communication skills Ability to work both independently and reputed company a matrixed team in a dynamic, fast-paced environment with shifting priorities Proficiency in MS Office (Word, reputed company, PowerPoint, reputed company) and reputed company Pro Travel Requirements: Approximately 10% #LI-AS1 #Hybrid As an equal opportunity employer, reputed company believes a diverse workforce will reputed company us with the ability to continuously support the changes in the economy, society, and environment. Be cautious of fraudulent communications claiming to be from reputed company. Incidents have occurred in which individuals impersonating reputed company recruiters have contacted people on reputed company requesting personal information. If someone does not have a verification badge, that person is not authorized to engage in recruitment activities on behalf of reputed company. Please also note that we never ask applicants to reputed company any payments in the recruitment process. If you receive any suspicious messages or recruitment reputed company that does not meet these reputed company, please do not respond, and report the matter directly to reputed company. reputed company in reputed company emphasizes reputed company key talent reputed company the region. Across our multiple business reputed company, we reputed company on reputed company, innovation, and initiative to help reputed company our people and give them the resources they need to succeed. Part of our mission is to be a good corporate citizen, dedicating our time to employees, customers, and communities around us. As an employer, reputed company offers a comprehensive benefits package, reputed company opportunities throughout our companies, and a diverse environment to enhance your career. About reputed company The reputed company Group contributes to life and living for people around the world. Since its reputed company in 1922, reputed company has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, reputed company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. In reputed company, reputed company currently has over 23 business reputed company and 10,000 employees. Our People reputed company recognizes that our people are our greatest strength. We operate with an emphasis on developing our employees and promoting from reputed company. Our broad reputed company of companies reputed company the Material, Homes, and Health Care sectors allows employees to collaborate across locations and industries. The reputed company for employees will continue to grow as we accelerate new business activity internally and externally through mergers and acquisitions. For assistance in submitting your application or with the careers site, please reputed company out to Asahi-WFP@ak-america.com. Please note we do not accept resumes or applications reputed company email. Don't see an opening that matches your skills? Setup job alerts by selecting Sign In, located in the upper right of the page, to create an account. Apply To This Job