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.

Description

This role is accountable for assisting in the development of strategies and the implementation of program management activities for safety alliance operations with license partners. This includes accurate, timely and compliant execution, maintenance of Astellas Pharmacovigilance Agreements (PVAs) to ensure compliance with worldwide regulatory requirements and Astellas policies.



The incumbent is the main point of contact for Astellas business development and for the affiliates, and is responsible to establish and maintain good business relations with Astellas' business partners. The timely execution, implementation and monitoring has a direct impact on Astellas compliance.



This role is also responsible for the leadership, management and direction of PVA function. In addition, the incumbent contributes to the development and successful implementation of the PV mission, objectives and the 1-3 year strategic plan. Finally, the incumbent may be a part of the BPM management team and may supervise direct reports

Essential Job Duties

Contributes to the strategy for PVA and as applicable, Intracompany Agreement program management.



Direct or indirect (e.g., mentor) line or outsourced resource management of the PVA group.



Builds collaborative working relationships with business development, alliance management and legal groups to enable timely identification of contracts requiring PVA development.



Serves as the main point of contact for matters relating to PVAs, Intracompany Agreements, and/or license partners.



Leads the establishment of PVA processes and workflows that create efficiencies between the partner, internal PV stakeholders, M&D and MA cross functional teams, business development and legal groups within the assigned area.



Alliance manages communications and remediation actions between PV and license partners, as necessary.



Serves as primary subject matter expert during audits or regulatory authority inspections. Coordinates any necessary CAPA actions stemming from partner audits or inspections. Liaise with CRQA regarding audit strategy for business partners.



Oversees and/or manages operations to ensure all PVAs are kept current and re-negotiations or terminations are initiated and completed in a timely fashion



Acts as the second line of escalation during PVA negotiations; may directly execute complex PVAs as needed. Mentors junior staff and assists in QC of all agreements.



Liaise with the QPPV office, providing information on PVA commitments, risks and metrics as needed.



Authors or contributes to procedures for PVA development and maintenance including guidance on negotiation boundaries and instructions for business owner involvement when boundaries are crossed; ensures maintenance of templates and procedures in line with regulations and Astellas policies; designs, implements and maintains adequate tracking tools for PVAs.



Monitors industry external environment and benchmarks PV safety alliance processes against best practices; represents GPV on industry alliance or peer groups.



Accountability:


Accountable for all PVAs. Implementation, management and monitoring of PVAs have a significant impact on Astellas' compliance to regulatory requirements and relationships with Business partners therefore the risk of this position is high. Non-compliance may have a significant impact on financial budget.

Project activities:


Oversees multiple projects managed by others.



Independently manages or leads complex projects.



Leads cross functional teams to establish and implement PVA strategy.



Quantitative Dimensions:


Line management of designated direct reports, as assigned.



Establishes key performance indicators and metric methodology to manage operations and drive quality and/or compliance improvement activities, as necessary



Manages and oversees approximately 100 PVA



Primary point of contact for > 50 business partners



Failing to meet contractual obligations can have financial consequences for Astellas



Critical interactions:


This role has critical and frequent interactions with senior management from license partners, Astellas' business development, legal, EU QPPV, CQA, affiliate DSOs, Affiliate general managers

Required Qualifications

Minimum BA/BS degree



Seven (7) + years' experience in the pharmaceutical industry with at least 6 years in Pharmacovigilance; preferably in the PVA space



Three + years managing staff and proven ability to supervise and mentor



Significant and demonstrable working knowledge of pharmacovigilance regulations and guidelines, including ICH and EU regulations

Preferred Qualifications

Advance degree (MBA/JD) 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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Category RAPV Strategy & Planning



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



EOE including Disability/Protected Veterans