Pv Affiliate Drug Safety Officer, Canada

**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.**

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 Headquart