Safety Manager

Job Responsibilities & Performance Standards

• Oversee the case handling process of safety cases from all sources within KPA PV
• Documents communications and keeps line management advised when there are problems emerging
• Provide information and assistance to KPA coworkers with regard to the Kowa global safety database system
• Implement training programs to qualify users to enter data for the Kowa global safety database system
• Prepare and/or review case report documents prior to submission to regulatory agencies
• Affords assistance in the preparation of regulatory safety submissions and other regulatory submissions, as needed
• Affords assistance and ensures regulatory compliance with AE reporting
• Affords assistance and ensures regulatory compliance with QA audits of pharmacovigilance functions
• Develop a working knowledge of and keep current on applicable foreign regulations
• Act as a ready reference person for safety personnel with regard to Kowa global safety database system
• Affords assistance with data intake and entry for adverse events into the Kowa global safety database system, as needed
• Affords assistance and ensures development and implementation of SOPs related to the PV department
• Act as QC reviewer within the safety department
• Review files and Case Report Forms (CRFs) in preparing documents for submission to FDA and NIH, as needed
• Keeps up to date with current regulatory guidelines and compliance regulations
• Abides by company policies regarding safety rules and regulations
• Adapts to various situations and adjusts to shifting priorities

Experience and Skills

• BS/BA degree in the pharmaceutical or biological sciences (or related field) is required; an advanced or professional degree strongly preferred
• Minimum 3 years of relevant experience is required, preferably within the pharmaceutical or biotechnology industry
• Excellent oral and written communications skills, excellent problem solving abilities, accurate data entry, and exceptional organizational skills required
• Maintains comprehensive proficiencies with Adobe Acrobat and Microsoft Office (e.g., Word and Excel) and associated modules
• Capable of working in a team-oriented and rapidly changing environment