Sr Medical Director – Medical Safety Evaluation (FT)

US-NJ-Jersey City
ID
2017-1024
# 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.

Responsibilities

      • Provides oversight of medical safety evaluation for global investigational products
      • 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

Education:

§  Medical Degree (MD or DO), and current medical license preferred

§  Board Certification or equivalent in a medical specialty and significant clinical experience

Professional Experience:

§  Minimum of 8 years pharmaceutical experience in Drug Safety, Medical Affairs, and/or Clinical Development

§  Minimum of 3 years’ experience leading a drug safety group in the pharmaceutical industry

§  Post-graduate training in clinical epidemiology and biostatistics is also desirable

Knowledge and Skills:

§  Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization

§  Thorough knowledge of US and International Safety reporting regulations and guidelines (in particular ICH clinical safety guidelines)

§  Experience in Phase II/III trials, especially with key activities (e.g. SMMP, CRO interaction, Safety-Clinical Database reconciliation, expedited reporting, AOSE, IND update, AR, ISS)

§  Demonstrated authorship of PSUR, RMP, and DSUR

§  Experience in supervising drug safety personnel, budgeting, organizing and planning for a growing drug safety department supporting multiple products and global expansion

§  Experience with ARIS-g or other safety database programs

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