Aggregate Safety Analyst

2 weeks ago

Markham, Ontario, Canada Astellas Full time

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
Reporting to the Global Team Lead for Aggregate Safety Analyses (ASA), the Aggregate Safety Analyst will contribute to and support maintenance of excellence in aggregate safety analyses and business practices to support the safety of Astellas' developmental and marketed products.

Essential Job Duties

The Aggregate Safety Analyst will be accountable for:

  • The creation of accurate, high-quality, and timely periodic safety reports (e.g. PBRERs, PADERs, DSURs, ACOs, etc.) and responses to assessment reports in a manner that is compliant with global regulatory requirements, business processes, and commitments in business partner agreements.
  • Working within the ASA and Regulatory Affairs and Pharmacovigilance (RAPV) budget.

The Aggregate Safety Analyst will be responsible for:

Strategy Development and Execution

  • Implementing 1–3-year ASA-specific objectives and plans as part of the overall global Safety Science and Labelling (SS&L) – ASA strategy and plans. Contributing to the successful execution of the global SS&L-ASA vision, mission, objectives, and plans.
  • Contributing to the implementation and successful execution of the RAPV mission, objectives and 3–5-year strategic plan.

Operations of ASA

  • Contributing to the execution and oversight of the worldwide ASA activities, including both in-house and out-sourced ASA and PV medical writing deliverables.
  • Timely and high-quality contribution to periodic safety reports and ad hoc (e.g. benefit-risk assessment documents in response to health authority requests) in terms of providing expertise in the collection of safety data and providing guidance on authoring safety/scientific sections and overall analyses and conclusions. This extends to supporting regulatory strategy and preparation of safety-related data for submission to health authorities.
  • Day-to-day management and oversight of the selected PV medical writing vendor(s) involved in supporting out-sourced periodic safety reports and other PV medical writing deliverables (e.g., responses to health authority requests, risk management plans, signal evaluation reports).
  • Providing expert guidance and close support to the GSOs, medical writers and other contributing authors of the periodic safety reports and responses to health authority assessment reports.
  • Supporting the preparation and maintenance of the global periodic report schedule.
  • Providing ASA contributions to risk management deliverables.
  • Maintaining up-to-date knowledge on regulations related to periodic safety reporting and assessing the impact of any changes on the ASA business processes.
  • Interfacing, collaborating, and communicating cross-functionally with stakeholders and contributors to ensure excellence in ASA activities, such as:
    • Building and maintaining close cross-departmental and cross-divisional relationships in RAPV, Research, Development, Quality Assurance, and Medical Affairs, and Commercial Capabilities.
    • Establishing effective and regular communication with RAPV stakeholders, such as the EU QPPV, Japan QPPV, Medical Safety, Regulatory Strategy, RAPV Operations, RAPV Affiliates, and global Safety Science and Labelling teams.
    • Liaising with business partners to ensure compliance with commitments within the business partner agreements.
    • Representing the ASA or global Safety Science and Labelling teams as a participant or lead on crossfunctional projects and initiatives.

Quality Management

  • Supports PV audits/inspections as ASA subject matter expert.
  • Accurate and timely execution and submission of responses to audit/inspection requests and findings associated with ASA.
  • Timely planning, creation, submission, implementation, maintenance and follow-up of corrective and preventive action plans related to ASA, ensuring feasibility and global alignment, where possible, in collaboration with the other functions within PV.
  • Recognizing, anticipating and communicating issues proactively.
  • Contributing to the establishment of best practices and development/update of business processes that are consistent with global periodic reporting regulatory guidelines and requirements.
  • Developing and presenting training to RAPV staff and vendors involved in aggregate safety analyses activities.
  • Representing RAPV in large (cross-) functional ASA training sessions promoting pharmacovigilance awareness and providing ASA specialist education across internal and external audiences.
  • Identifying, developing, implementing, and communicating process improvement tools, systems and procedures within RAPV to assure optimal efficiency and consistency.
  • May participate in the ASA Quality Team.

People & Organization Management

This position reports to the Team Lead, Aggregate Safety Analyses and is a member of the global Aggregate Safety Analyses Team within the global Safety Sciences and Labelling group in RAPV. Peers and collaborators may be co-located in the US, EU/UK, India, and Japan.

Contributes to an environment to enable each member of Aggregate Safety Analyses to optimally operate in a matrix environment of RAPV and Astellas.

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