Senior Manager, Aggregate Reports
Company: Mitsubishi Tanabe Pharma Development America Inc.
Location: Jersey City
Posted on: January 8, 2022
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi
Tanabe Pharma Development America, Inc. (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. MTDA is rapidly
expanding our operation across all functional areas to assist in
the research and development of new products for the U.S. market.
The Senior Manager, 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 Senior Manager,
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. Responsibilities
- 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 certain sections of DSURs, PBRERs, and RMPs as
- 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
- Performs other departmental duties as assigned. Qualifications
- Minimum BA/BS in life/health sciences or related field;
advanced degree preferred
- Minimum of 6 years of pharmaceutical industry experience in
Drug Safety including case processing; at least 2 years of
experience specifically in Drug Safety aggregate reports
- 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 Sorry the Share
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Keywords: Mitsubishi Tanabe Pharma Development America Inc., Jersey City , Senior Manager, Aggregate Reports, Executive , Jersey City, New Jersey
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