Takeda Pharmaceuticals North America has built a 
solid foundation on successful products, 
principles, people, and research. We currently 
have the following position available in Lake 
Forest, IL: Sr. Manager, Pharmacoepidemiology & 
Epidemiology

The Sr. Manager provides consultation for and 
facilitating the systematic planning, collection, 
and synthesis of global pharmacoepidemiology 
information for all Takeda products in 
collaboration with among others 
Pharmacovigilance, Clinical Sciences, Regulatory 
Affairs, Medical Affairs etc. The following are 
key elements of the position's objectives:
• The incumbent provides global strategies and 
pharmacoepidemiology research plans to further 
the commercial and clinical objectives for the 
therapeutic area or product
• The incumbent directs globally the designs and 
conduct of qualitative and quantitative analyses 
of pharmacoepidemiology studies (cohort studies, 
case-control studies etc.) to generate data that 
are important for decision-making in each stage 
of a product's lifecycle
 
ACCOUNTABILITES:
• Direct comprehensive pharmacoepidemiology 
strategies to help achieve product strategic 
targets and objectives (includes Clinical, 
Pharmacovigilance, Regulatory and Commercial).
• Oversee natural history of disease studies to 
understand the inherent risks associated with the 
indications for which medications are approved or 
under development
• Translate the vision of pharmacoepidemiology in 
cross-functional objectives and activities
• Manage the use of longitudinal databases, SRS 
databases and literature
1) to develop an understanding of potential 
safety issues for new compounds and new 
indications, based on experience with related 
compounds, and  
2) to contribute to position papers relative to 
marketed products
• Effective communication of pharmacoepidemiology 
plans and deliverables in U.S. and globally, both 
to internal and external audiences.
• Present pharmacoepidemiology data and evidence 
to regulatory agencies and advisors/opinion 
leaders and convey logic
• Partner with Clinical Sciences and 
Pharmacovigilance in clinical trial planning, 
creation and conduct of risk management 
strategies utilizing pharmacoepidemiology 
research techniques.
• Provide pharmacoepidemiology expertise during 
due diligence and make recommendation based on 
the findings
• Represent, Takeda at pharmacoepidemiology 
meetings, and relevant Regulatory Agency meetings
• Be an advocate for pharmacoepidemiology activities
• Set goals, supervise, and evaluate performance 
of staff as well as planning growth of personnel

QUALIFICATIONS:
• Required: Masters in Pharmacoepidemiology, or 
Epidemiology, with minimum 8 years experience in 
the pharmaceutical industry, CRO health-related 
consulting company, or academia (or a combination 
of afore-mentioned)
• Preferred: PhD in Pharmacoepidemiology, 
Epidemiology, or MD with a Masters in 
Pharmacoepidemiology or Epidemiology, or PharmD 
with a Masters in Pharmacoepidemiology or 
Epidemiology with minimum 5 years experience in 
Pharmacoepidemiology, or Epidemiology, in the 
pharmaceutical industry, CRO health-related 
consulting company, or academia (or a combination 
of afore-mentioned).
• Experience with risk management planning is 
desired.
• Ability to follow scientific arguments, 
identify pharmacoepidemiology scientific data needs
• Extensive experience with observational 
database analyses and methodologies
• Ability to obtain pharmacoepidemiology 
regulatory opinions, assimilate data effectively 
define an epidemiology regulatory strategy and 
communicate with FDA and other Health Authorities 
in meetings as required
• Ability to understand the market and regulatory 
challenges for Takeda products; and to critically 
review competitors' data and assimilate 
pharmacoepidemiology strategies that take such 
environments into consideration.
• Excellent qualitative and quantitative 
pharmacoepidemiology skills, including with 
regards to study design and analysis of health 
insurance claims and other automated healthcare 
databases.
• Familiarity with SAS or similar software for 
data manipulation and data tabulation
• Excellent problem-solving and interpersonal 
skills are required, as are a high degree of 
self-motivation, initiative and attention to detail.
• Ability to work independently as well as in a 
team, and to manage multiple projects under tight 
deadlines are also essential.
• Setting goals, supervising, and evaluating 
performance of staff as well as planning growth 
of personnel.
• Excellent scientific writing, technical skills.

TRAVEL REQUIREMENTS:
• 30% Required Domestic and International travel.
 

APPLICATION INSTRUCTIONS:
To learn more about this position and to apply 
online, please visit the following site and 
reference job number: 0900594 

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