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 development and maintenance of excellence in Data Assurance/Medical Consistency.
Contributes to the development, implementation, and successful execution of the GPV objectives and 1–3-year operational plan, supporting the overall PV mission.
Responsible for ensuring the quality and medical correctness of (contracted) work delivered under the global PV Case Management function.
Ensures a variety of QC and training activities.
Works extensively with vendor personnel and internal staff to ensure the high data quality required to support the ongoing assurance of the safety profile of Astellas products.
Essential Job Duties
Strategy Development and Execution
Responsible for implementation and execution of various QC measures in ICSR processing.
Provides medical expertise to the case processing teams and serves as an authority for medical decision-making on ICSRs for the team.
Participates in the successful execution of global PV vision, mission, objectives, and plans.
Contributes to the successful implementation of annual strategic goals and objectives.
Act as a back-up for the Team Lead, PV Data & Medical Assurance
Accountable for medical and safety expertise and responsible for:
ICSR Processing:
Implement global ICSR case processing policies and strategies.
Operational execution of ICSR processing and evaluation (Data collection, Triage, Translation, Data entry, MedDRA coding, Case Assessment & Medical Evaluation, and Follow-up)
First line of decision making on case processing matters for prioritization, FU significance, seriousness, listedness, coding queries, etc.
Responsibility for performing or initiating case corrections as needed, and for deciding on the type of corrections required.
Provision of SME services for ICSR processing queries by the vendor.
Ensure Medical analysis and review and follow-up for medical consistency at the highest standards.
Is responsible for the correct (medical/technical) content of training materials.
Ensure and maintain excellence, consistency, completeness, and accuracy in case processing and (medical) case evaluation
Provide expert medical and safety knowledge and advice and decide on individual case assessment and literature case review.
Build and maintain close relationships with Global Safety Officers (GSOs)
Serves as first instance for triage of Emerging Safety Issues.
Literature Management:
Product Quality Complaint Management:
Provide medical support to PV Case Management and GMS/GSS in PQC assessment and evaluation.
Ensure excellence, consistency, completeness, and accuracy in triage and medical evaluation of PQCs.
Quality, Data Assurance & Business Information management
Implement global QC policies and strategies as required.
Represents team Inspections, PV audits and non-PV audits (GMP/GCP) as an SME on medical case quality matters.
Supports creation and maintenance of Conventions, MedDRA coding and synonyms and auto-labelling.
Responsible to justify the Astellas opinion regarding individual case assessment to external bodies (e.g. during regulatory inspections and in responses to authority requests)
Ensures correct decision-making on and execution of study-case unblinding (SUSAR unblinding as well as end of study unblinding) by performing appropriate review and providing advice.
Serves as liaison with DSOs on ICSR matters and ensures appropriate information flow (ICSR collection, outbound FUs etc.) and quality thereof.
Cooperate with the Team Lead, PV Data & Medical Assurance, and fellow colleagues to ensure global medical consistency.
Training:
Responsible for (medical review) training of vendor and internal staff as required.
Represents PV in large (cross-) functional training sessions promoting pharmacovigilance awareness and providing specialist education across internal and external audiences.
Providing specialist education to PV, non-PV staff and vendor staff performing PV-related activities.
Presents medical/safety overview to new Astellas employees to ensure timely recognition of emerging safety issues.
People & Organization Management
Contribute to the effective implementation of optimal organizational structure(s) which maximizes on the use of resources, taking the global impact into consideration, and reflects business needs and conditions.
Maintenance of effective collaborations with relevant external stakeholders:
With Global Development Operations on case unblinding.
With the global case processing vendor to ensure appropriate quality of cases processed.
With Regulatory Authorities, license partners and internal functions in providing medical/PV expertise to ICSR processing-related matters
With the GSOs concerning emerging safety issues and the medical assessment of PQCs.
Required Qualifications
Registered licensed M.D. or equivalent.
At least 2 years of clinical practice with direct patient management
Medical review / medical assessment experience and expertise within Pharmacovigilance
Minimum of 10 years relevant experience in pharmacovigilance or combined PV/RA/QA, and/or clinical Development
In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations
Proven experience with establishing and maintaining (GxP) Qualities Management System.
In–depth personal experience and understanding of Process Management, Standards & Training as they apply throughout the entire pharmaceutical compound/product life cycle
Skills and competencies:
Demonstrates leadership to ensure case processing, medical evaluation and case quality are maintained at highest standards at all times
Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus on medical matters and able to develop effective relationships through collaboration.
Demonstrated ability to resolve conflict situations, think tactically, and build consensus across the global organization. Able to generate insights and leverage learnings at the individual, team, and functional level.
Able to lead meetings, present orally and interact with external bodies.
Excellent communication and presentation skills in English (written and spoken)
Ability to leverage all available resources internally and externally.
Preferred Qualifications
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.
Category RAPV Ops
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
