Careers – Mitsubishi Tanabe Pharma America, Inc. – Medical
Director, Medical Safety Evaluation in Jersey City, New Jersey |
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Log back in! Medical Director, Medical Safety Evaluation Job
Locations US-NJ-Jersey City ID 2019-1330 # 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 Medical Director, Medical Safety Evaluation (MSE) is
responsible for leading product level safety analysis and strategic
medical safety management for 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
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 Leads overall medical safety evaluation for
assigned global investigational products and clinical development
Participates in FDA or other health authority safety
interactions/responses as the product safety lead.
Has full accountability for all aspects of the global drug
safety function, including development/delivery of a quality
Pharmacovigilance system for assigned products/activities. Is
the primary safety representative between global/local groups
and external groups (Drug Safety Monitoring Boards, regulatory
agencies, physician communities, external experts, and CROs) on
product safety related issues.
Leads safety signal detection activities and chairs global cross
functional safety teams, with appropriate
communication/escalation. Oversees/conducts signal tracking
for products according to regulatory requirements and corporate
Completes/reviews medical assessments of safety data [Periodic
Safety Update Reports (PSURs, DSUR), safety sections for
labels/IBs/regulatory submissions (e.g. IND/pre-NDA briefing books,
safety queries), Safety Surveillance Plans, and CCDS] as
appropriate and ensures the benefit/risk information is
Oversees development and preparation of Risk Management Plans
(RMPs), safety portions (e.g., 2.7.4, ISS), and 120-day safety
updates for regulatory approval filings.
Interacts extensively with regional and corporate departments to
provide medical/drug safety strategic input to clinical research
(scientific and operational), MTDA regulatory affairs, and global
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.
Oversees data collection, processing, assessment, and
preparation of case reports, annual reports, and periodic reports
to ensure the timely submission to international regulatory
agencies as well as ensure quality medical assessment (e,g., case
medical review oversight).
Provides overview of the safety aspects of the planning,
execution, data collection and interpretation of clinical
research. Performs medical review/approval of medically coded
safety data, including adverse events, medical history and
Accountable for the performance and results of the Drug Safety
department and provides medical advice, training, and support.
Implements department plans and priorities to address business and
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.
Supports the development of a Global Pharmacovigilance Team that
is fully compliant with all local regulatory requirements. Improves
organizational efficiency through outsourcing and other
Provides input to senior management, as requested, regarding
safety aspects of brand strategy, key messages, data review, and
future data needs.
Performs other departmental duties as assigned.
Qualifications Medical Degree (MD or DO); current medical
Board Certification or equivalent in a medical specialty and
significant clinical experience desired
Post-graduate training in clinical epidemiology and
biostatistics is also desirable
Minimum of 8 years in the pharmaceutical industry with at least
5 years of experience in US and international Drug Safety, Medical
Affairs, and/or Clinical Development functions
Previous experience with leading strategic safety medical
evaluation activities (e.g., Medical Director/Global Safety Officer
level) at a product level is required
Experience writing/leading pharmaceutical regulatory or clinical
research safety documents, including periodic safety reports, IB
safety sections, and risk management plans required
Experience as lead safety physician for Phase I-III trials,
especially with key safety activities (e.g. SMMP, CRO interaction,
AOSE, IND update, AR, ISS) required
Experience with safety databases, including medical review of
case reports (pre-marketed and post-marketed products) required
Contributor for PSUR, RMP, and DSUR documents
Experience as lead safety physician in post-marketing/phase IV
studies and surveys with key activities (e.g. patient registries,
survey protocols) preferred
Familiarity with US and International Safety reporting
regulations and guidelines (in particular, ICH clinical safety
Strong interpersonal skills and ability to collaborate
effectively with other groups in a matrix organization
Required to travel domestically and internationally typically up
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