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 company based on global revenues
and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce
Pharma.
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.
Purpose and Scope
Global Safety Officer is accountable for proactive safety surveillance of
Astellas drug products, both those in development and marketed products,
including leading PV Product Responsible Teams as a pharmacovigilance
specialist, ensuring the medical safety for the assigned compounds or products,
contributing to an optimal benefit/risk profile and responsible for the design
and successful implementation of signal management and risk management
strategies for assigned products.
Essential Job Duties
- Leads PV Product Responsible Teams for assigned products, co-chairs Global
Development Safety Management Teams, and participates in Global Development
Core Teams and Global Medical Affairs Core Medical Teams as the
pharmacovigilance specialist, ensuring the medical safety of products for the
assigned Global TA and contributing to an optimal benefit-risk profile.
- Responsible and accountable for the timely identification and communication
of emerging safety issues and safety updates of the Company Core Data Sheet,
Investigator’s Brochure and local product labeling. This also includes
responsibility for effective and regular communication with the Global TA
Group Lead and with the applicable QPPV.
- Responsible and accountable for the design of safety surveillance strategies,
management of safety signals for Astellas drug products, both those in
development and marketed products, for the collection and identification of
safety signals using safety data for signal surveillance activities,
categorization and prioritization of safety signals and for authoring,
medical review and, as appropriate, approval of safety evaluation reports
(SERs), working closely with Safety Science.
- Responsible and accountable for the risk management of assigned Astellas drug
products, both those in development and marketed products, the development
and submission of the Risk Management Plan (RMP) and for the execution of
risk management strategies in collaboration with internal and external
stakeholders, working closely with Safety Science.
- Responsible and accountable for timely and high-quality contribution to
periodic and ad hoc (e.g. Health authority requests) safety reports for
assigned products in terms of authoring and review of medical sections, the
overall medical-scientific analyses and conclusions.
- Responsible and accountable for the ongoing monitoring and assessment of the
safety profile of assigned Astellas developmental and marketed products as a
member of study teams and for representing PV in the design, conduct,
analysis and reporting of Phase 1 – Phase 3 clinical trials and
Post-Authorization Studies.
Qualifications
Required Qualifications
- Bachelor's degree required; advanced professional degree in scientific,
health-related field (e.g. PharmD or PhD) strongly preferred (pharmaceutical
industry experience in a relevant therapeutic area preferred);
- Minimum of at least 6 years of experience with M.D., D.O., PhD, or PharmD
degree, and at least 8 years of experience with bachelor’s or master’s
degree, in the pharmaceutical industry and/or a relevant health science
setting (such as academia). Direct exposure to pharmacovigilance functions,
additional regulatory and/or clinical development experience is a plus.
- In-depth understanding of safety regulations for both marketed and
investigational products, and excellent knowledge of regional and global
authority requirements, including ICH, and other applicable requirements,
able to influence decisions relating to patient safety and assessment of
benefit-risk.
Preferred Qualifications
- M.D. strongly preferred (board certification in medical specialty or
pharmaceutical industry experience in a therapeutic area 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.
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