Pharmacoepidemiologist (Associate Director)

Astellas; Markham; On-site; CAD 80,000 - 120,000; Full time

Job summary

An established industry player in the pharmaceutical sector is seeking a Pharmacoepidemiologist to join their innovative team. This role focuses on developing and implementing strategies within the Epidemiology group, generating crucial insights related to drug safety and efficacy. The ideal candidate will thrive in a collaborative environment, utilizing advanced methodologies to support non-interventional studies and ensuring compliance with global regulatory standards. If you are passionate about making a positive impact on patient lives through scientific progress, this opportunity offers a chance to contribute meaningfully to healthcare advancements.

Qualifications

• Expertise in developing safety assessments for drug products.
• Experience in designing and executing observational studies.

Responsibilities

• Develop and implement safety assessments using scientific literature.
• Assist in designing and submitting observational studies for safety.

Skills

Pharmacoepidemiology

Observational Research

Data Analysis

Safety Assessments

Methodological Expertise

Education

PhD in Epidemiology

Master's in Public Health

Tools

Statistical Software (SAS, R)

Epidemiology Tools

Job description

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, transplant, and our impressive pipeline in women’s health, blindness, 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. We are among the Top 30 global biopharma companies based on revenues.

In Canada, we are expanding to meet the opportunities presented by our legacy brands and innovative treatments.

We seek candidates who thrive in our entrepreneurial, empowering environment where talent and leadership flourish. Do your values align with our Astellas Way — patient focus, ownership, results, openness, and integrity? We would love to hear from you.

From day one, everyone at Astellas shares the responsibility to create a brighter future for patients worldwide. We foster exceptional relationships with our employees to help them thrive, promote innovation, and deliver outstanding results. Our culture empowers our people to pursue bold ideas and ambitious goals, to be accountable for high standards, and to embody a competitive, solutions-oriented mindset.

Our expertise, science, and technology define us as 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 developing and implementing strategies and activities within the Epidemiology group. This role involves generating epidemiologic evidence and insights related to the use and safety of Astellas products, providing guidance on observational data analysis methods, and interpreting study results. The role also supports Astellas-sponsored non-interventional studies managed centrally or by affiliates.

Essential Job Duties

• Develop and implement safety assessments for drug products using scientific literature and external databases to determine background rates of events in target populations.

• Assist with designing, executing, and ensuring timely submission of observational studies (non-interventional post-authorization safety studies) to fulfill Astellas’ post-marketing commitments, adhering to good epidemiology practices.

• Contribute to developing and utilizing new methodologies and advanced pharmacoepidemiology tools for evaluating potential safety signals.

• Provide scientific support for safety risk management activities requiring pharmacoepidemiology expertise.

• Offer methodological expertise in observational research to partners in Regulatory Affairs, Pharmacovigilance, and R&D.

• Use appropriate methodologies to research disease natural history and therapy usage to understand standards of practice and support future clinical development and product assessment.

• Assist in developing effectiveness assessments for risk minimization plans, safety risk strategies, and patient safety registries, evaluating their feasibility.

• Deliver high-quality epidemiology outputs across the portfolio.

• Ensure all epidemiology activities comply with global regulatory obligations.

• Contribute to developing procedural documents for the Epidemiology function.

• Support the Group Lead by providing input for Epidemiology objectives within the Global Safety Science and Labelling department.

ReqID: 25-PJT00290