Pharmacoepidemiologist (Associate Director)

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.

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.

Category Safety Sciences and Labelling

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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