Job Description

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:

Leads Pharmacovigilance (PV) at affiliate level, with line management responsibility as applicable. Acts in alignment with global functional and local Brand Team objectives and priorities as appropriate, with overall responsibility for all products in scope of the affiliate(s).



In close coordination with the RAPV Affiliate Lead, this role is responsible for:


Development and execution of the affiliate PV strategy, planning and objectives.



Effective operation and oversight of the local PV system and acting as the local PV contact person / local Qualified Person for PV (L-QPPV), as applicable.



Responsible for acting as the local Drug Safety Officer (DSO) and manage its related duties.



Compliance with applicable policies / procedures, laws / regulations / guidelines and contractual agreements as well as continuous improvement of the affiliate's PV Quality Management System, including effective regulatory intelligence and change management.



Representing Astellas towards local Health Authorities and pharmaceutical industry associations on all matters PV, as applicable.



Responsible for monitoring and reviewing the Pharmacovigilance activities at affiliate level, whilst overseeing the systematic collection and documentation of Product Safety information and related activities and passing information to all other relevant stakeholders that could include the Health Authority.



Responsible for collecting relevant publicly available PV information and use this information to inform relevant people.

Essential Job Duties

Liaison on a strategic and operational level with the Affiliate RAPV Lead, headquarters, EU-QPPV / L-QPPV and local Business Partners, as applicable - on all matters PV.



Anticipates fluctuating workload and ensures adequate resourcing and prioritization.



Acts as primary contact for (potential) safety issues at the responsible country / countries and/or affiliate(s).



Mentors and manages other affiliate staff with PV responsibilities in a matrix setting, as applicable.



Pro-actively identifies and mitigates risks in collaboration with cross-functional teams.



Supports maintaining Astellas' reputation through protection of patient safety.



Provides strategic and operational support to brand-centric activities (e.g., Early Access Programs and Patient Support Programs).



The responsibilities of a DSO furthermore include, but are not limited to:


High-quality PV record management.



Develops and maintains local procedures to ensure adherence to applicable PV requirements.



Provides adequate PV training as required.



Effectively works cross-functionally to ensure compliant and up-to-date PV-related contractual arrangements.



Adequately collects and manages product safety information from all applicable sources and ensures that the



Global Safety Database (GSD) is used to record source information accurately, timely and completely at



affiliate level. Maintains effective oversight of local / regional / global suppliers that manage this activity permanently or temporarily.



Ensures that safety information (Adverse Events) received from all sources (e.g literature search, Market Research, Patient Support, Digital Media) by the affiliate are collected, translated and forwarded to designated Regional Global PV Headquarter, in compliance with required timelines (reporting timelines), quality guidelines and standards, as applicable.



Overseeing and monitoring compliance of case documentation, as applicable.



Distributes and/or submits ICSRs to relevant destinations, as applicable.



Periodically reviews local literature, as applicable.



Distributes / submits aggregate reports such as Periodic Safety Update Reports (PSURs) to Competent Authorities (CAs) and Suspected Unexpected Serious Adverse Reaction (SUSAR) Line Listings (LLs) to Investigators, as required. Manages local translations and creation of annexes and cover letters where required.



Distributes / submits Risk Management Plans, where required with local translations (as required) and cover letter. Creation and maintenance of L-RMPs as applicable.



Adequately and timely implements additional Risk Minimization Measures, as applicable.



Manages local signal detection- and management-related activities.



Manages outsourced partners to ensure PV activities are conducted according to the relevant procedures, as applicable



Responsible for the development and maintenance of locally applicable PV Quality documents.



Ensures filing, storage and archiving of PV documentation in accordance with PV regulations and with Astellas policies and procedures



Request to have access to, and be aware of, the affiliate business continuity plan (for example system failure and other disasters) in relation to PV activities. Responsible for ensuring a local mechanism is in place for 24/7 availability to enable appropriate handling of potential urgent safety issues by the affiliate.



Ensures timely and compliant management of locally required post-authorization studies, as applicable.



Ensures effective PV business continuity arrangements and PV-related third party life-cycle management.



Leads PV system audits, inspections and management of non-conformances and Corrective Actions and Preventive Action (CAPA) plans.



Appropriately handles potential safety issues as well as timely communication of information that requires notification to local Health Authorities and timely responses to local Health Authority requests.



Ensures up-to-date content for the (L-)PV System Master File (PSMF).



Supports management of the affiliate PV budget in a cost-efficient manner.

Required Qualifications

BS Degree in pharmacy, medical, life sciences, chemistry or similar



5+ years relevant experience in a PV role and/or combined PV/QA/QA; to include direct contact and engagement with national Health Authority.

Preferred Qualification

Demonstrated knowledge of Canadian PV regulations and guidelines (other jurisdictions is an asset)



Relevant external pharmaceutical (professional) training with an advanced professional degree

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 RAPV Affiliates: Established Markets



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



EOE including Disability/Protected Veterans