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Senior Safety Specialist
2 months ago
Mitsubishi Tanabe Pharma America, Inc. is seeking a highly skilled Senior Safety Specialist to join our team in the Office of Quality, Standards, and Training (QST) within the Drug Safety department.
Key Responsibilities- Quality Performance Assessment: Assess the quality performance of regional Drug Safety Department, developing quality monitoring tools and performing quality assessment of assigned safety reports.
- Standard Operating Procedures (SOPs): Facilitate development of SOPs and other process-related documents for Drug Safety in a regional and global capacity.
- Training and Development: Develop and implement the regional Drug Safety department training program, maintain SOP/WIN training, and facilitate training classes for Drug Safety and other departments as needed.
- Regulatory Compliance: Verify compliance with standard operating procedures, Food and Drug Administration and ICH guidelines and regulations, and global regulations for the management of safety-related activities.
- Global and Regional Development: Participate in the global and regional development and revision of drug safety processes, policies, guidelines, SOPs, and training materials.
- Training and Support: Provide applicable training within Drug Safety, other internal functions within MTPA, and any other external parties or organizations.
- Deviation and Nonconformity Identification: Identify deviations and nonconformities to reinforce compliance with applicable SOP/WIN training for the relevant functions.
- Reporting and Measurement: Measure accuracy and timelines for reporting of safety information to Health Authorities, per internal processing timelines, and exchange with partners.
- Representative and Investigator: Represent the Drug Safety department for the QST responsibilities during audits and inspections, and perform investigations into deviations, determine root causes, assign appropriate CAPAs, and facilitate the closure of CAPAs.
- Education: Minimum B.A./B.S. in life/health sciences or related field, advanced degree (Pharm.D., Ph.D.) or medical degree (M.D., D.O.) with Board Certification or equivalent in a medical specialty and clinical experience desirable.
- Experience: Minimum of 1-3 years of pharmaceutical industry experience in Drug Safety, Medical Affairs, Clinical Development, or pharmaceutical industry, experience in clinical safety and post-marketing safety surveillance, experience in periodic reports and/or ad hoc health authority safety requests, and experience providing support to safety management team in areas including risk assessment, evaluation, and management.
- Skills: Solid understanding of regulations as they apply to drug surveillance for both IND and NDA reporting, working knowledge of Food and Drug Administration Regulations, including but not limited to: 21 CFR, 312 and 314, GCP and ICH, strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization, strong analytical and problem-solving skills, and working knowledge of Drug Safety databases.
Mitsubishi Tanabe Pharma America, Inc. is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, a research-driven pharmaceutical company with a storied reputation more than 300 years in the making. Our parent company has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in Neurology in Parkinson's (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology.
We offer a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance, and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.
