Overview

Entrepreneurial Spirit, Rooted in Tradition . Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), and amyotrophic lateral sclerosis (ALS) and Parkinson’s (PD)..

MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare diseases treatments including RADICAVA® (edaravone) injectables in 2017, EXSERVAN™ (riluzole) oral film in 2021, and RADICAVA® (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.

Manages Drug Safety Data Systems to ensure the timely creation, deployment and maintenance of databases required by MTDA Drug Safety projects. Analyzes study protocol and project requirement(s), identifies drug safety data quality rules, and design and program reports based on the data reporting requirement in accordance with SOPs, client requirements, and regulatory guidelines.

The Senior Safety Specialist will contribute to all activities supported by the Office of Quality, Standards, and Training (QST) within the Drug Safety department. The Senior Safety Specialist will assess the quality performance of regional Drug Safety Department, developing quality monitoring tools and performing quality assessment of assigned safety reports (Global Development and Post-marketing Products and/or local development/post-marketing products) including but not limited to reviewing clinical trial documents, Safety Monitoring Plans, safety data reconciliation documents, and other safety documents prepared for and/or affecting compliance of regulatory submission. The Senior Safety Specialist will facilitate development of standard operating procedures (SOPs) and other process-related documents (e.g., working instructions) for Drug Safety in a regional and global capacity. The incumbent will also develop and implement the regional Drug Safety department training program, maintain SOP/WIN training, and facilitate training classes (GDSEC seminars) for Drug Safety and other departments as needed.

Responsibilities

• Verifies compliance with standard operating procedures, Food and Drug Administration and ICH guidelines and regulations, and global regulations for the management of safety related activities.

• Performs regional QST activities in collaboration with Headquarter QST function.

• Participates in the global and regional development and revision of drug safety processes, policies, guidelines, SOPs, and training materials.

• Provides applicable training within Drug Safety, other internal functions within MTPA and any other external parties or organizations.

• Assists in the development and implementation of training programs for Drug Safety and non-Drug Safety personnel in the company or for third- party vendors, conducting needs assessment, and establishing related training curriculum based on the job matrix.

• Coordinates and facilitates training seminars for Drug Safety (GDSEC Seminars) and other departments within the MTPA organization as well as globally (MTPE and MTPC) as needed.

• Supports the maintenance and tracking of all Drug Safety training materials including learning tests.

• Identifies deviations and nonconformities to reinforce compliance with applicable SOP/WIN training for the relevant functions.

• Measures accuracy and timelines for reporting of safety information to Health Authorities, per internal processing timelines, and exchange with partners.

• Represents the Drug Safety department for the QST responsibilities during audits and inspections.

• Performs investigations into deviations, determines root causes, assigns appropriate CAPAs, and facilitates the closure of CAPAs.

• Develops CAPA Effectiveness Checks, monitoring and facilitates the closure of Effectiveness Checks.

• Supports the development and maintenance of the inspection readiness program for the Drug Safety organization.

• Performs other departmental duties as assigned.

Qualifications

• 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.

• 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.

• Experience providing support to safety management team in areas including risk assessment, evaluation and management.

• Possess 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.

• Working knowledge of Drug Safety databases.

Our Value Proposition:

Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.

MTP provides 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.

The salary range for this position is $78,000 - $124,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.

This position is eligible to participate in our annual Short-Term Incentive (STI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.

Job Locations US-NJ-Jersey City

Job ID 2024-1866

# of Openings 1

Category Drug Safety

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.