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
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:
- 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
Qualifications
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, FDA,EU and/or other regional
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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