Manager, Global Drug Safety & Pharmacovigilance

The Asahi Kasei Group operates with a commitment of creating for tomorrow. 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 variety of skills to help us achieve our commitment.

Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.

Company:
Veloxis Pharmaceuticals, Inc.

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This position is primarily responsible for providing management level oversight, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, quality, inspection readiness and operational excellence. The incumbent in this position also serves as a safety liaison with the Company's cross-functional teams, license partners and the contract safety organizations responsible for global drug safety and pharmacovigilance.

The base compensation range for this role is $120-130K. Base 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.

Summary of Key Responsibilities

• Serve as resource and contact for other functions within the company for pharmacovigilance operational activities
• Responsible for overall vendor performance and vendor service outputs (delivered timely and on budget) including, but not limited to:
  • Oversight of US AE call center;
  • Oversight of adverse event processing by outsourced vendor, including the review and monitoring of compliance through various monitoring reports / KPIs;
  • Participation in quality audits of individual case safety reports (ICSR) following vendor processing, with a specific focus on accuracy of narrative to reflect source documentation, MedDRA coding, expectedness against RSIs and appropriateness of queries to seek follow-up from the clinical sites / reporter;
  • Oversight of adverse event reconciliation between safety and clinical databases, and adverse events exchanged between licensing partners;
  • Review of safety-related section of aggregate reports (DSUR, PSUR/PBRER, PADER, RMP);
  • Review and approval of pharmacovigilance related documents submitted to the Trial Master File (TMF);
  • Provision of vendor project specific training;
  • Collaboration with vendors to develop Safety Management Plans (SMP) and relevant forms and templates;
  • Collaboration with vendors to develop process-related 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 standard 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 contracts and forecasting activities;
• Assist in management of license partner safety data exchange agreements (SDEA);
• Assist management in establishing and coordinating all product safety operations functions in accordance with regulations and the Company's policies and procedures;
• Assist in preparation and review of regulatory submissions, such as safety reports and aggregate / periodic reports;
• Represent the Company in product safety meetings with its cross-functional teams, license partners and contract safety organization;
• Provide training to Company personnel and third parties for pharmacovigilance requirements and compliance;
• Maintain current 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 related healthcare 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 complex operational and data-related issues
• Strong understanding of current 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 within a matrixed team in a dynamic, fast-paced environment with shifting priorities
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro

Travel Requirements: Approximately 10%

#LI-AS1 #Hybrid

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.