Senior Manager, Pharmacovigilance Quality Assurance

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 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.

Description

Responsible for the development and maintenance of excellence in Pharmacovigilance QA (PVQA) activities supporting the PV system and Quality Assurance. The Manger, PVQA provides support in ensuring Astellas processes and comply with national and international requirements for the pharmacovigilance function and the collection and systems reporting of safety information.

This activity comprises both auditing as directed, and consultancy activities. This role develops and manages a sub selection of the quality system and operations across region. As QA Expert, provides QA consultancy (identifying risk, leading continuous improvement) services to the organization for the Pharmacovigilance and related functions. This role will coordinate the preparation, the conduct and the follow up of Regulatory Inspections as directed.

Essential Job Duties

• Execution of regional, cross regional and / or global multiple audit programs. This includes the planning, conducting, and reporting of audits, liaising with customers on audit findings and the follow up thereof. It also incorporates interpretation of findings, providing trending information, root cause analyses and identifying lessons learned for Astellas organization continuous improvement. Lead the proper management and follow up of the findings and improvement areas.

Provide unsupervised GPvP expert advice to key personnel. This includes and is not limited to : Developing training materials and providing GPvP training internally and externally to both small and large professional organizations. It also encompasses coaching of QA colleagues and other functions, on QA related processes.

Reviewing of the responses / communication provided to health authorities (e.g. in case of inspection).

Interpreting health authorities’ requirements and advising in their implementation across Astellas organization.

Requirements

Required Qualifications

Preferred Qualifications