Manager, Drug Safety, Aggregate Reports (Hybrid) - Mitsubishi Tanabe Pharma

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 Aggregate Reports will function as the overall project manager for the development and finalization of assigned key safety documents such as Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs). The individual will also maintain and manage agreement and contract updates related to drug safety vendors and support the logistical management of global safety governance escalation meetings including agenda creation with the application of good documentation practice.

The Manager, Drug Safety Aggregate Reports collaborates with internal and external stakeholders managing data information and exchange between all parties involved. The incumbent leads stakeholder meetings and troubleshoots and mitigates issues throughout the development process of each key deliverable.

• Creates and maintains the DSUR, PBRER and RMP development project schedules in compliance with global procedures and assigns deliverables to key identified stakeholders.
• Negotiates with appropriate stakeholders to ensure that DSUR, PBRER, and RMP commitments are met.
• Works closely with the Safety Medical Writer to develop DSURs, PBRERs, and RMPs, manage their review cycles, and ensure they are finalized in time for Health Authority submission.
• Writes sections of DSURs, PBRERs, and RMPs.
• Tracks activities in close collaboration with the Global Safety Team (GST), Safety Data Management (SDM), and Safety Medical Writer, ensuring the accurate inclusion of benefit-risk assessments and risk characterizations into DSURs, PBRERs, and RMPs.
• Collaborates closely with Global Safety Team (GST) Chairpersons and Coordinators to manage and facilitate meeting logistics, documentation, and scheduling for multiple clinical safety project teams in a cross-functional environment.
• Maintains and manages agreement and contract updates related to drug safety vendors.
• Maintains working knowledge of company policies and assigned products as related to drug safety roles and responsibilities.
• Maintains working knowledge of the document management system used to review and finalize key safety documents.
• Mentors junior pharmacovigilance (PV) personnel in their functions.
• Participate in the development of global drug safety processes, policies, guidelines, SOPs/WINs, and training materials for assigned projects.
• Perform other departmental duties as assigned.

• Minimum BA/BS in in a healthcare-related or Biomedical Science field; advanced degree preferred
• Minimum of 5 years of pharmaceutical industry experience in Drug Safety including case processing; at least 2 years of experience specifically in Drug Safety aggregate reports management
• Pharmacovigilance medical writing experience of safety documents (DSUR, PBRER, IND/NDA, RMPs)
• Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization.
• Excellent oral and written communications skills
• Strong attention to detail
• Strong analytical and problem-solving skills
• 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.
• Experience 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.