• Associate Medical Director/Medical Director, Medical Safety Evaluation (Remote)

    Job Locations US-NJ-Jersey City
    ID
    2018-1199
    # of Openings
    1
    Category
    Drug Safety
  • Overview

    Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

     

    Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.

     

    The Associate Medical Director/Medical Director – Medical Safety Evaluation (MSE) is responsible for the management of the Medical Safety Evaluation Office of global products throughout the product lifecycle within the Global Drug Safety and Evaluation Center (GDSEC). Incumbent implements corporate policies to ensure the safety of the product in global development portfolio.  The Associate Medical Director/Medical Director is accountable for providing medical input to the assessment of the safety profile for each drug and for appropriate and timely regulatory reporting of safety issues.

    Responsibilities

    • Provides medical safety evaluation for global investigational products.
    • Participates in FDA or other health authority interactions with support or supervision from his/her manager.
    • Has full accountability for all aspects of the global drug safety function, including development/delivery of a quality Pharmacovigilance system.
    • Leads safety signal detection activities.
    • Reviews and approves documents such as periodic safety update reports and ensures the benefit/risk information is accurate.
    • Improves organizational efficiency through outsourcing and other alliances.
    • Provides medical advice, training, and support.
    • Develops and implements strategies for Pharmacovigilance business plans in accordance with long-term company strategic plans. This includes active involvement and coordination with local and international Pharmacovigilance directors and physicians.
    • Provides primary liaison between global/local groups and external groups (Drug Safety Monitoring Boards, regulatory agencies, physician communities, and CROs) on product safety related issues.
    • Interacts extensively with regional and corporate departments to provide medical/drug safety input to clinical research (scientific and operational), MTDA regulatory affairs, and global quality/manufacturing.
    • Oversees data collection, processing, assessment, and preparation of case reports, annual reports, and periodic reports to ensure the timely submission to international regulatory agencies.
    • Provides overview of the safety aspects of the planning, execution, data collection and interpretation of clinical research.
    • Oversees/conducts signal tracking for products according to regulatory requirements and corporate business strategy.
    • Provides input to senior management, as requested, regarding safety aspects of brand strategy, key messages, data review, and future data needs.
    • Oversees development and preparation of Risk Management Actions Plans for regulatory filings.
    • Completes/reviews medical assessments of safety data [Periodic Safety Update Reports (PSURs, DSUR), Safety Statements, Safety Surveillance Plans, and Discussion Documents; as appropriate).
    • Performs medical review/approval of medically coded safety data, including adverse events, medical history and concomitant medications.
    • Supports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements.
    • Works with cross-functional commercial teams to build awareness of the safety of company products in the medical community, including supporting company sponsored Advisory Boards, participating in medical symposia, publishing, attending media events, and other activities.
    • Accountable for the performance and results of the Drug Safety department. Implements department plans and priorities to address business and operational challenges.
    • Performs other departmental duties as assigned.

    Qualifications

    • Medical Degree (MD or DO); current medical license preferred
    • Board Certification or equivalent in a medical specialty and significant clinical experience desired
    • Minimum of 1-3 years pharmaceutical experience in US and international Drug Safety, Medical Affairs, and/or Clinical Development functions
    • Exposure or experience writing pharmaceutical regulatory or clinical research documents, including periodic safety reports and risk management plans
    • Post-graduate training in clinical epidemiology and biostatistics is also desirable
    • Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization
    • Familiarity with US and International Safety reporting regulations and guidelines (in particular, ICH clinical safety guidelines)
    • Exposure or experience in Phase I-III trials, especially with key activities (e.g. SMMP, CRO interaction, Safety-Clinical Database reconciliation, expedited reporting, AOSE, IND update, AR, ISS)
    • Exposure or experience in post-marketing/phase IV studies and surveys with key activities (e.g. patient registries, survey protocols)
    • Contributor for PSUR, RMP, and DSUR documents
    • Exposure or experience with safety databases
    • Willingness to travel domestically and internationally typically up to 20%
    • Ability to sit or stand for long periods of time
    • Manual dexterity required to operate office equipment, i.e. computers, phones, copy machine/printer
    • Ability to carry, handle and reach for objects
    • Ability to lift and pull up to 15 pounds

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed