Safety Pharmacoepidemiology (SPE) contributes to cross-functional teams that are responsible for generation of primary data or analysis of secondary data sources to contribute to the assessment of the benefit-risk profile of Takeda products as needed to satisfy post-authorization regulatory commitments and safety reporting. SPE provides subject matter expertise into the development of regulatory documents that are submitted to regulatory agencies to update the periodic benefit-risk profile of Takeda products and sits as a member of product Safety Monitoring Teams that assess safety signals of marketed Takeda products. The role objective of this position is to provide technical and strategic guidance to meet strategic objectives in the generation and dissemination of data to characterize the safety profile of Takeda products.
Key position objectives are to:
- Partner with Takeda teams by undertaking and leading projects to support safety messaging of marketed products including:
- Design and planning of observational studies to assess safety of Takeda products
- Analysis and interpretation of product and disease epidemiologic data
- Strategic input into regulatory documents, such as Risk Management Plans, Periodic Benefit-Risk Evaluation Report, and responses to enquiries of regulatory agencies
- Issues resolution regarding clinical safety of developmental and marketed products, including evaluation of new hypotheses, appraisal of published epidemiological studies concerning Takeda products, defence of marketed products
- Provide expertise and input in the identification and quantification of risks associated with exposure to developmental or marketed products, by applying epidemiological data and observational research techniques
Network with external researchers in the field in order to remain on top of best practices and enhance Takeda’s visibility in the area of pharmacoepidemiology
- Collaborates within a multidisciplinary, matrixed organization and leads the design and execution of observational studies to generate evidence to support the benefit-risk profile of Takeda products.
- Provides input into regulatory documents such as Risk Management Plans, Periodic Benefit-Risk Evaluation Reports, and responses to regulatory queries
- Provides technical expertise towards issues resolution regarding clinical safety of developmental and marketed products, including evaluation of new hypotheses, appraisal of published epidemiological studies concerning Takeda products, defence of marketed products
- Provides epidemiologic support to project teams, including detailed knowledge on epidemiology of target diseases, published literature on topics of interest, and data sources suitable for epidemiologic studies
- Effectively manages external research partners to ensure projects are scientifically rigorous.
- Performs, as appropriate, relevant research activities which may include, but not limited to:
- Development of RFPs for protocol design, analytic plan, conduct, analyses of observational safety studies such as systematic literature reviews and meta-analyses, indirect treatment comparisons, observational research using existing data and/or generation of prospective primary data.
- Familiarity with software for management and analysis of data.
- Follows best practices for data collection, conduct and reporting of real-world evidence studies.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Combination of academic training and practical experience in health outcomes research and epidemiology is required. This may consist of:
- Doctoral degree (e.g., Ph.D., Sc.D. or Dr.P.H., PharmD) in a relevant discipline such as, but not limited to, epidemiology, health services research, public health, statistics or decision science, or pharmacy science plus 3 years practical experience.
- Master’s degree in a related discipline (as noted above), plus 5 years practical experience.
- Practical experience (number of years as noted above) in performing epidemiology research, in any setting, including life sciences company, research organization, academic institution or governmental agency, is required. Experience in design and execution of pharmacoepidemiology studies a plus.
- Knowledge of the advanced epidemiologic methods involved in the quantification of potential safety signals, the determination of causal relationships for potential safety signals and the application of epidemiologic methods.
- Excellent qualitative and quantitative epidemiological skills, including study design and analysis of health insurance claims and other automated healthcare databases.
- Familiarity with software for management and analysis of epidemiologic data.
- Demonstrated experience in conducting and interpreting statistical analysis.
- Ability to work collaboratively and effectively in a multicultural and cross functional team environment is expected as well as ability to work independently.
- Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required.
- Record of high-quality, peer-reviewed publications is preferred.
- No licenses or certifications are required for this position.
What Takeda can offer you:
- 10-20% Domestic and International
More about us:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and a company match of charitable contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work Policy.
Employees may also be eligible for Short-Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Locations
Boston, MAWorker Type