Pharmacovigilance Associate

**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.**

**Description**:
In coordination with / or in the absence of the Canada DSO:
This role is responsible for acting as deputy to the local Drug Safety Officer (DSO) and performing PV activities

conducted at the local affiliate by maintaining the operational excellence.

Responsible for supporting the implementation of procedures to ensure compliance with both local and regional

PV regulations and Astellas global and regional policies and procedures.

Responsible for monitoring and reviewing the PV activities at the local affiliate level, whilst supporting the oversight

of the systematic collection and documentation of Product Safety Information (PSI) and related activities and

passing information to all other relevant stakeholders that could include the Health Authorities (HA).

**Essential Job Duties**

ICSR Case intake and local process

Ensure correct case processing by completing quality check in PV database.

Ensure timelines are met for each activity to ensure compliance and monitoring at an affiliate level.

Local PV Quality Management System

Maintain appropriate tools and databases as necessary for optimal functioning and oversight of the local PV department.

Oversight on execution of routine reconciliations of various databases and with PV partners.

Support the implementation of PV Agreements and PV contracts with local vendors.

Ensure correct filing and archiving of related documents according to Good Documentation Practices

Support with PV Health Canada inspections and internal (PV) audits.

People and Organization Management
- Responsible for acting as the local Drug Safety Officer (DSO) Back Up and manage its related duties.

**Required Qualifications**

Minimum BA/BS, Degree in Health Science, Life Science, Medical Science or equivalent by experience.

Minimum of 3 years relevant Canadian experience in Pharmacovigilance (PV) or a combination of PV/RA/QA.

Experience with PV systems and case processing.

Awareness and hands
- on experience with maintaining (GxP) Quality Management Systems

Robust understanding and experience of local PV regulations and guidelines. Sound knowledge of the PV landscape and associated procedures within the country/region.

Experience with/ and understanding of PV Processes, Standards &Training.

Experience with preparation for (PV) audits, collaborating in audit and post-audit reporting phase and monitoring of CAPA actions.

Proficiency in English & French.

**Preferred Qualifications**

Knowledge of Canada and US-FDA pharmacovigilance regulations.

Knowledge of Drug Safety Systems, specifically Life Sphere Multivigilance

Experience with working cross functionally in a matrixed organization.

Strong interpersonal skills; able to negotiate and build consensus for plans and priorities.

**Additional Information**

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.

LI-SS

Category Affiliate Management

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

EOE including Disability/Protected Veterans