Safety Manager

Job Purpose:

The primary purpose of the Safety Manager at Kowa Pharmaceuticals America, Inc. (KPA) is to support the company through management of the pharmacovigilance activities for the members of the KPA Pharmacovigilance Department. This position will act as liaison between KPA and Kowa Company Limited (KCL) to ensure smooth implementation and day-to-day operation of the safety information systems and assists with ensuring accurate completion of safety data intake and data entry in compliance with applicable U.S. regulatory submission guidelines of safety cases.

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;
• Assists in the preparation of regulatory safety submissions and other regulatory submissions, as needed;
• Assists in the preparation, review, and update of SOPs, as needed;
• Assists and ensures regulatory compliance with AE reporting;
• Assists in 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;
• Assists with data intake and entry for adverse events into the Kowa global safety database system, as needed;
• Assist in 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; and
• Performs other duties as assigned.

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.

International Considerations

Individual is expected to contribute to the maintenance and improvement of Kowa global PV systems in collaboration with PV colleagues across KCL, KPA, KPE and KRI, including:

• Maintaining the Kowa global safety database including system upgrade, patch adaption, MedDRA updates, and contact with Oracle support desk for trouble shooting.
• Serving as the liaison with KCL, KPE PV staff to exchange ICSRs via Argus for regional regulatory reporting.
• Ensuring the compliance of electric ICSR reporting to FDA.
• Retrieving and reviewing the safety data from FDA AERS.
• Reviewing global PV-SOPs at the request from KCL.
• Reviewing and maintaining KPA SOPs as they relate to regional and global PV activities.
• Attending to global PV meetings (GET and GSC), as requested.
• Providing support to KRI upon request for establishment and operation of safety data exchange procedures with CROs for clinical trials sponsored by KCL/KRI.
• Planning and execution of Argus user and administrator training to KPA staff in collaboration with designated global safety system guidelines.
• Supporting KCL to prepare global PV documents on pitavastatin including DSUR, PBRER, RMP, CCSI and coding manual.

Other Considerations

Travel (including international travel from time to time) to visit partners and attend relevant conferences or meetings is a critical part of the job, so the candidate must be willing to travel up to 20% of the time. Flexibility in scheduling travel also required.

NOTE: The information presented, while not an exact or exhaustive listing, describes the work, performance standards, and qualifications typically required of positions of employees in this job. A specific position description or employee performance plan may differ as long as it is consistent with the core Responsibilities, Standards and Qualifications for that job.