Senior Safety Specialist

2 days ago

Jersey City, New Jersey, United States Mitsubishi Tanabe Pharma Full time
About Mitsubishi Tanabe Pharma America

Mitsubishi Tanabe Pharma America is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation, a research-driven pharmaceutical company with a storied reputation spanning over 300 years. Our parent company has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis, diabetes mellitus, amyotrophic lateral sclerosis, and is currently developing medicines in neurology, immunology, and oncology.

Job Summary

We are seeking a Senior Safety Specialist to contribute to all activities supported by the Office of Quality, Standards, and Training (QST) within the Drug Safety department. The successful candidate will assess the quality performance of regional Drug Safety Department, developing quality monitoring tools and performing quality assessment of assigned safety reports.

Key Responsibilities
  • 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.
  • Perform regional QST activities in collaboration with Headquarter QST function.
  • Participate in the global and regional development and revision of drug safety processes, policies, guidelines, SOPs, and training materials.
  • Provide applicable training within Drug Safety, other internal functions within MTPA, and any other external parties or organizations.
  • Assist in the development and implementation of training programs for Drug Safety and non-Drug Safety personnel in the company or for third-party vendors.
  • Coordinate and facilitate training seminars for Drug Safety (GDSEC Seminars) and other departments within the MTPA organization as well as globally (MTPE and MTPC) as needed.
  • Support the maintenance and tracking of all Drug Safety training materials, including learning tests.
  • Identify deviations and nonconformities to reinforce compliance with applicable SOP/WIN training for the relevant functions.
  • Measure accuracy and timelines for reporting of safety information to Health Authorities, per internal processing timelines, and exchange with partners.
  • Represent the Drug Safety department for the QST responsibilities during audits and inspections.
  • Perform investigations into deviations, determine root causes, assign appropriate CAPAs, and facilitate the closure of CAPAs.
  • Develop CAPA Effectiveness Checks, monitoring, and facilitate the closure of Effectiveness Checks.
  • Support the development and maintenance of the inspection readiness program for the Drug Safety organization.
Requirements
  • 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.
About the Role

This is an exciting opportunity to join a dynamic team and contribute to the development of innovative medicines. As a Senior Safety Specialist, you will play a critical role in ensuring the quality and compliance of our safety-related activities.

What We Offer

Mitsubishi Tanabe Pharma America offers a competitive benefits package, including medical and dental health benefits, short-term and long-term disability plans, company-paid and supplemental life insurance, and additional voluntary benefits. We also 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.

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