About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.
Learn more at Astellas.com .
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
This position is hybrid and will require you to be onsite 2 days per week in our Leiden, Netherlands office.
Astellas’ Responsible Flexibility Guidelines Statement- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Purpose & Scope
- The Risk Management Officer is responsible for providing clinical, methodological, and strategic input to global or regional project and product management teams for the development of risk management activities. The role supports teams implementing risk management strategies throughout the lifecycle of the drug. The individual applies strong leadership, communication skills, and risk management expertise to influence effectively and ensure strong collaboration across Global Risk Assessment and Pharmacovigilance (Global RAPV) and ex Risk Assessment and Pharmacovigilance (ex RAPV) functions and sites.
- The Risk Management Officer partners with Medical Safety, Epidemiology, Signal Management Officers, and other functions within the Safety Sciences and Labeling group, as well as Regulatory Leads, the European Union and United Kingdom Qualified Person for Pharmacovigilance (EU & UK QPPV), and other Global RAPV functions to deliver key compliance related or team commissioned outputs within agreed timelines. In addition to working with RAPV stakeholders, the Risk Management Officer also collaborates periodically with Statistics, Legal, Pre Clinical disciplines, and other key stakeholders to support the delivery of risk management strategies that enhance Therapeutic Area Strategy and project or product lifecycle management.
Role and Responsibilities
- Collaborate on signal detection — Work closely with Epidemiology and Signal Management Officers to advance scientific methods for pre and post marketing signal detection, risk evaluation, identification of important risks, and selection of risk minimization strategies.
- Ensure alignment in safety reports — Partner with Aggregate Safety Analyses to ensure risk management strategies and benefit risk assessments are accurately reflected in DSUR, PSUR, and PBRER reports.
- Contribute to regulatory documentation — Support development of key documents describing important risks and mitigation strategies, including Investigator Brochures and NDA/MAA summary documents.
- Lead compliance and tracking activities — Lead or support compliance tasks such as maintaining PSMF sections, preparing for inspections, and developing tracking mechanisms for risk assessment and mitigation strategies.
- Drive collaboration and process improvement — Foster strong partnerships across RAPV and cross functional teams, gather stakeholder feedback to improve risk management processes, and support knowledge building across therapeutic areas.
Required Qualifications
- Bachelor’s or advanced degree in health related sciences (MD, PhD, PharmD) or equivalent.
- Extensive pharmaceutical industry experience in Drug Safety, Epidemiology, or Clinical Development, including direct global risk management experience (preferred).
- Demonstrated strategic thinking, global mindset, strong organizational and leadership skills, results orientation, and ability to work effectively in a matrix environment.
- Excellent understanding of ICH, U.S., and EU pharmacovigilance regulations and requirements, with experience in worldwide safety reporting guidelines.
- Strong interpersonal skills and proven ability to work effectively across cultures and functions, including leading cross functional teams without direct reporting lines.
- Proficiency in Windows, Word, Excel, Outlook, PowerPoint, and strong English communication skills (oral and written) to operate effectively in a global environment.
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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