At Astellas, we strive to become a cutting-edge, value-driven life science
innovator. This means working at the forefront of healthcare change to turn
innovative science into VALUE for patients.
What sets us apart is our focus on patients, our pioneering innovation, our
collaborative culture, and the passion of our talented people.
Making a positive impact on patients’ lives is the purpose behind everything we
do. At Astellas, we are relentless in our pursuit of scientific progress and in
tackling unmet medical needs, demonstrated by our legacy in oncology, overactive
bladder and transplant and our impressive pipeline in women's health, blindness
and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted
protein degradation.
About Us:
We are a global pharmaceutical company headquartered in Japan, with a team of
more than 14,000 managing operations in approximately 70 countries around the
world. We are in the Top 30 global biopharma companies based on global revenues.
In Canada, we are growing to meet the exciting opportunities realized by our
legacy brands and rich pipeline of innovative treatments.
We are looking for candidates who will thrive in our entrepreneurial and
empowering environment where talent and leadership flourish. Do your values
align with our Astellas Way - patient focus, ownership, results, openness and
integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for
creating a brighter future for patients around the world. We nurture exceptional
relationships with our employees to allow them to thrive, foster innovation, and
deliver exceptional business results. We work to create a culture where our
people feel empowered to pursue brave ideas and ambitious outcomes, to have the
confidence to be accountable for a higher standard of performance and embody a
competitive and solutions-oriented mindset.
Our expertise, science and technology make us a pharma company. Our open and
diverse culture is what makes us uniquely Astellas.
Description
Reporting to the Pharmacoepidemiology Group Lead, the Pharmacoepidemiologist is
responsible for the development and implementation of strategy and activities in
the Epidemiology group. This position will be responsible for generation of
epidemiologic evidence and insights related to the use and safety of Astellas
products. This position will also provide guidance on methods to analyze
observational data, and the interpretation of pharmacoepidemiology study
analyses and results. Pharmacoepidemiology supports Astellas-sponsored
non-interventional studies managed centrally or by an affiliate.
Essential Job Duties
- Develops and implements safety assessments for drug products using scientific
literature and external databases and registries to assist in determining
background rates of events of interest in target populations.
- Assists with the design, execution and on-time submission of tailored
observational studies (non-interventional post-authorization safety studies)
that are constructed to fulfill Astellas’ post-marketing commitments using
good epidemiology practice.
- Contributes to the development and utilization of new methodologies and
advanced pharmacoepidemiology tools for the evaluation of potential safety
signals.
- Provides scientific support for Astellas safety risk management activities
where pharmacoepidemiology expertise, insights and approaches are required.
- Provides pharmacoepidemiology methodologic expertise in observational
research to partners in Regulatory Affairs and Pharmacovigilance, and across
R&D
- Utilizes appropriate methodologies and tools in researching the natural
history of diseases and use of therapies to understand the standards of
practice, and to aid future clinical development of new chemical/molecular
entities and/or assessment of the use of Astellas marketed products.
- Assists with developing effectiveness assessments of product risk
minimization plans, safety risk assessment strategies and patient safety
registries; assesses feasibility of proposals.
- Executes high quality scientific, portfolio-wide epidemiology deliverables.
- Ensures that all epidemiology activities comply with regulatory obligations
and requirements worldwide
- Assists in the development of procedural documents applicable to the
Epidemiology function.
- May assist the Pharmacoepidemiology Group Lead by providing input for the
development and implementation of specific Epidemiology objectives in the
department of Global Safety Science and Labelling.
Qualifications
Required Qualifications
- At least 6-7 years pharmaceutical/health related industry experience.
- Epidemiology research related experience.
- Working knowledge of pharmacovigilance regulations and guidelines, including
US, EU and ICH regulations and guidelines.
Skills and competencies:
- Demonstrates effective leadership/collaboration skills within a matrix
environment.
- Understands and can interpret quantitative methods.
- Knowledge of principles, theories, and practices of epidemiology research
methods, techniques, sources of information, surveillance methodology and
tools.
- Knowledge of applicable laws, rules, regulations, policies and procedures
regulating the pharmaceutical industry.
- Knowledge of relevant therapeutic areas and products.
- Ability to compose and produce rigorous technical and scientific reports,
documents and related materials.
- Ability to drive decisions or solve problems by identifying key facts,
exploring alternatives, and proposing quality solutions.
- Strong oral and written communications skills, including for presentations
and publications.
- Global mindset and experience in Epidemiology.
- Savvy with MS Tools.
- Understands PV global regulations and guidelines.
Preferred Qualifications
- PhD in Epidemiology or related field preferred.
Additional Information
Astellas Pharma Canada welcomes and encourages applications from people with
disabilities. Accommodations are available on request for candidates taking part
in all aspects of the hiring process.
Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition
of employment. Reasonable accommodation to this policy may be granted for a
valid accommodation request under human rights legislation.
No telephone inquiries, in-person applications, or agencies please. While we
appreciate all applications, only candidates under consideration will be
contacted.
