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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), 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.

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 disease treatments including RADICAVA® (edaravone) injectables in 2017 and RADICAVA® (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain,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.

As a Manager, Drug Safety Data, you will be responsible for managing and analyzing safety data to ensure the safety of pharmaceutical products including post marketing and investigational compound. You will work closely with cross-functional teams, including medical, regulatory, and clinical departments, to ensure compliance with regulatory requirements and company policies. Additionally, you will lead initiatives to automate and digitalize pharmacovigilance processes to improve efficiency and accuracy.

Responsibilities

• Oversee the collection, processing, and reporting of adverse event data.

• Ensure compliance with regulatory requirements for safety reporting.

• Lead the development and maintenance of standard operating procedures (SOPs) related to safety data management.

• Collaborate with cross-functional teams to support safety surveillance activities.

• Prepare line listings and summary tabulations aggregated periodic safety reports (PBRERs, DSURs, PADERs).

• Maintain selection criteria and dictionaries for Reference Safety Information (RSIs).

• Be responsible to obtain ongoing study data from various EDC systems.

• Participate in regulatory inspections and audits and manage audit responses.

• Gather and document user requirements for safety data reporting.

• Prepare and manage report requirement documents to ensure accurate and compliant safety reporting.

• Conduct and document validation activities for pharmacovigilance systems and processes.

• Lead automation and digitalization initiatives in pharmacovigilance processes.

• Implement automated solutions for adverse event reporting and data management.

• Utilize digital tools and technologies to enhance pharmacovigilance operations.

Qualifications

• BA/BS in a life or computer science. Master’s degree in data science, Computer Science preferred or a combination of education and experience

• Minimum of 5 years of experience in pharmacovigilance, drug safety, or a related field.

• Experience in managing safety data and adverse event reporting.

• Demonstrated experience in preparing and reviewing safety reports (e.g., PBRERs, DSURs, PADERs).

• Proven track record of successfully leading pharmacovigilance projects and initiatives.

• Experience with pharmacovigilance databases and safety management systems.

• Hands-on experience with Argus, ArisG, or other safety databases.

• Skilled in using safety reporting tool such as IBM Cognos and BusinessObjects

• Proficiency in visualization tool, MS-PowerBI or SpotFire for data analysis and dashboard generation

• Champion in data management, and data quality control processes and validation processes.

• Working knowledge in using data analysis tools and software (e.g., SAS, R).

• Experience with regulatory inspections and audits.

• Participation in FDA, Health Canada, or other regulatory inspections.

• Experience in responding to regulatory inquiries and audit findings.

• In-depth knowledge of pharmacovigilance regulations and guidelines.

• Understanding of ICH guidelines, GVP modules, and other global regulatory requirements.

• Familiarity with FDA, Health Canada, and other international regulatory bodies' expectations for drug safety.

• Demonstrate knowledge in research design, system validation, E2B / CDISC, standard coding dictionaries (MedDRA)

• Experience with regulatory submissions (e.g., NDA, MAA, DSUR, PBRER, PADER, etc.)

• Strong analytical and problem-solving skills.

• Ability to analyze complex safety data and identify trends or signals.

• Proficiency in statistical analysis and risk assessment methodologies.

• Excellent communication and interpersonal skills.

• Ability to effectively communicate complex safety information to various stakeholders.

• Strong written and verbal communication skills for preparing safety reports and presentations.

• Detail-oriented with strong organizational skills.

• Ability to manage multiple projects and deadlines simultaneously.

• Strong attention to detail and commitment to data accuracy and integrity.

• Experience in handling user requirements and report requirement documents.

• Ability to engage with stakeholders to understand and document user requirements for safety data reporting.

• Proficiency in preparing and managing report requirement documents.

• Knowledge of validation processes.

• Understanding of validation principles and practices in pharmacovigilance.

• Ability to conduct and document validation activities to ensure system reliability and regulatory compliance.

• Skills in automation and digitalization.

• Knowledge of automated solutions and digital tools for pharmacovigilance.

• Ability to implement and manage automated processes to improve efficiency and accuracy in safety data management.

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 $112,000 - $179,000. 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 2024-1876

# 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.