Manager, Drug Safety, Safety Scientist (Hybrid) - Mitsubishi Tanabe Pharma

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 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.

The Manager, Drug Safety will support signal detection activities and medical analyses to support evaluation and characterization of safety topics for products working closely with Drug Safety Global Safety Team (GST) Chair (Medical Director). The Manager, Drug Safety will perform signal management process activities for assigned products, including combination products (drug and device) including signal tracking, safety data analysis, and presenting in the GST governance meetings. Incumbent will perform the review of worldwide medical/scientific literature to identify information applicable for inclusion in aggregate reports and for potential safety signals, and author safety aggregate reports as needed. The Manager, Drug performs medical analyses for risk characterization to develop Risk Management Plans (RMPs). The Manager will also draft responses for regulatory authority inquires on aggregate reports and author applicable information and data for marketing applications [New Drug Applications (NDA), New Drug Submission (NDS)], Amendments, Supplements, Safety Reports, and general correspondence for all assigned.

Responsibilities

• Partners with Medical Directors, Global Safety Team (GST) Chair to provide strategic product risk management throughout product lifecycle for assigned products.
• Provides expertise to develop and manage product’s safety/risk profile, includes performing safety analyses and evaluations, interpret safety information to make a recommendation and lead safety data review meetings as needed.
• Draws on knowledge and/or experience in qualitative and quantitative signal detection methods.
• Performs robust and independent clinical safety analysis with a focus on medical interpretation of safety data.
• Analyzes and interprets data from multiple sources (clinical trials, safety databases, literature, etc.).
• Collaborates with Medical Directors and cross-functional members of the GST to initiate and complete GST deliverables as required. Support GST activities (e.g. preparing and presenting data, compiling meeting minutes, updating signal tracking information).
• Authors safety data summarization of applicable information for New Drug Applications (NDA), New Drug Submissions (NDS), Amendments, Supplements, Safety Reports, and general correspondence for all assigned products.
• Leads and produces high-quality and timely written documentation for PV safety documents [Periodic Safety Update Reports (PBRER, DSUR, PADER), safety sections for labels/IBs/regulatory submissions (e.g., IND/pre-NDA briefing books, safety queries), Safety Surveillance Plans, and CCDS].
• Supports the writing of regional REMS/RMPs for assigned MTPG global products as needed.
• Provides support for US FDA and Health Authority safety interactions/responses for assigned MTPG products regarding safety and risk management, both written and verbal.
• Utilizes technical combination product and device knowledge, regulatory expertise and lessons learned to shape MTPG best practices.
• Collaborates effectively across a global matrix organization to support global cross-functional consensus on benefit-risk analysis, safety conclusions, and their impact for product safety profile.
• Mentor junior pharmacovigilance (PV) personnel in their functions.
• Performs other departmental duties as assigned.
• Collaborates with, communicates with, and as required oversees the work of external service providers or suppliers directly involved in the drug development process.

Qualifications

• Minimum BA/BS in in a healthcare-related or Biomedical Science field; advanced degree preferred
• Minimum of 5 years in the pharmaceutical industry experience with at least 2 years of experience in US and international Drug Safety.
• Solid understanding of scientific principles and regulatory requirements relevant to global drug and drug-device combination product development, registration, and post-market support
• Strong knowledge of global regulatory requirements related to pharmacovigilance and drug safety.
• Strong knowledge in signal detection, evaluation, aggregate data analysis, and interpretation
• Experience using analytics tools (MS Power BI, IBM Cognos, SpotFire, etc.)
• Solid understanding of US and International Safety reporting regulations and guidelines (in particular, ICH clinical safety guidelines)
• Excellent interpersonal, relationship management, and decision-making skills with the ability to collaborate effectively with other cross-functional groups in a matrix organization.
• Excellent communication skills, verbal and written.
• Required to travel domestically and internationally typically up to 10-15%

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.