Manager, Drug Safety Data

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 Drug Safety Data Manager will be responsible for development of SDTM, presentation of data in table and listing, and visualization for clinical safety monitoring as well as post-marketing reporting requirements. Works closes with other functional groups such as medical safety evaluation team, pharmacovigilance operation, case processing, quality, and compliance team to collect the requirement and improve the deliverables. Ensure all the activities are quality controlled and validated. Resolves Drug Safety data integrity issues and addresses database design inconsistencies over time by improving standardized approach.

Participate Drug Safety system upgrade project and support to innovate digitalization of PV operation by applying automation and AI technologies as business expands and regulation requires.

Responsibilities

Clinical Safety Data handling with SAS programming and analytical tasks

• Create SDTM datasets for the clinical Safety Data using SAS based on the specifications and SDTM Implementation Guide as per requirement and standards of the company
• Understand and utilize SDTM specification and Annotated eCRF according to SDTM variables to apply study specific variations in addition to the general standardization.
• Extensive working knowledge on CDISC/SDTM standards.
• Create various SDTM datasets and ADAM datasets as per Specifications for on-going studies for safety signal detection.
• Work with Clinical Trials data such as Demographic data, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data (Lab data), ECG, Vital Signs and other data domain as requested.
• Generate tables, listings and graphs with SAS Basic and SAS Macro.
• Develop and validated SAS programs to produce analysis datasets and reports including routine and ad-hoc requests.
• Apply SDTM dataset or Argus data to be used in visualization tool (SpotFire or Power BI) to visualize the output for safety analytics
• Independently analyze and investigate data issues and solve technically complex problems.
• Deliver accurate, high quality, and on-time of clinical programming deliverables.

 

Post-market Drug Safety Data handling with IBM Cognos and SAS programming and analytical tasks

• Create Drug Safety reports using safety reporting tool (IBM Cognos) which is a data mart of the Safety database (Argus)
• Deliver and enhance compliance monitoring metrics for the PV activities
• Provides aggregate reports data output using the reporting tool
• Provide signal detection report from internal (Argus) and external (FAERS) Safety Databases
• Participate in validation of the reports for quality and inspection readiness

 

Special tasks

• Maintain MedDRA dictionary to deliver output with the latest MedDRA version
• Develop and maintain systematic criteria and algorithm of selecting adverse event terms for the labelled or expected event and safety signal/risk and make them up to date along with the MedDRA version.
• Maintain and support Sharepoint Signal Tracker system. Utilize Power Automate feature to apply workflow to support signal management process
• Participate Argus version up project
• Evaluate automation and AI technologies to enhance PV activities and operation

 

Project Management tasks

• Meet with clients to take user requirements and clarify specific requirements of each project
• Delegate and train routine reports for other team members to operate
• Track project performance, specifically to analyze the successful completion of short- and long-term goals
• Develop comprehensive project plans to be shared with clients as well as other staff members
• Use and continually develop leadership skills
• Communicate project status and key project issues to subject matter experts.

Qualifications

• 5+ years pharmaceutical experience in clinical and/or safety setting for investigational or post-marketing product.
• Proficient in SAS, SAS Enterprise Guide and SQL.
• Experience in various R programming packages/tools
• Experience in visualization tool (e.g. MS-Power BI, SpotFire)
• Experience in reporting tool (e.g. IBM Cognos or BusinessObjects)
• Strong experience in using data management technologies (Safety Data system (e.g. Argus, Arisg), clinical data management systems, electronic data capture, data review tools, data warehousing)
• Experience in developing Drug Safety Data management standards (CDISC, SDTM, ADAM)
• Experience in the use of computer software systems (Share point, MS-Access, Word, Excel, PowerPoint, Microsoft Project, Visio, etc.)
• Excellent oral and written communication skills
• Good project management skills
• Programming and reports validation experience
• Excellent problem solving, analytical, organization and time management skills
• Customer focus, flexibility
• Experience with clinical studies.
• 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.)
• Positive attitude and an ability to creatively use programming skills across variety of tasks in the Clinical Programming area.
• Strong oral and written communication and presentation skills, including experience with multicultural audiences.
• Critical thinking skills, ability to set priorities and develop strategies/studies to answer complex research questions
• Experience managing multiple projects, often complex in nature and with both internal and external stakeholders under short timelines.
• Ability to work effectively in a cross-functional, project team environment and manage several ongoing projects
• Ability to conceptualize the presentation of results (e.g., develop layout of tables and figures for inclusion in analysis plans).
• Ability to clearly communicate written results in drafts of study reports, presentations, publications, and other key project documents.
• Ability to contribute to written processes to ensure consistent and quality deliverables.

 

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 $93,000 - $149,000. 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.

 

Employment Type: OTHER