Global Safety Officer
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
As the Global Safety Officer, you will be accountable for proactive safety surveillance of Astellas drug products, encompassing both those in development and marketed products. You will lead Pharmacovigilance (PV) Product Responsible Teams as a pharmacovigilance specialist, ensuring the medical safety of assigned compounds or products. Your contributions will focus on optimizing the benefit/risk profile of these products and include designing and successfully implementing signal management and risk management strategies for assigned products.
Hybrid Working:
At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
Responsibilities:
- Lead PV Product Responsible Teams for assigned products, co-chair Global Development Safety Management Teams, and participate in Global Development Core Teams and Global Medical Affairs Core Medical Teams, ensuring medical safety and an optimal benefit-risk profile.
- Ensure timely identification and communication of emerging safety issues and updates to the Company Core Data Sheet, Investigator’s Brochure, and local product labeling, while maintaining effective communication with the Global TA Group Lead and applicable QPPV.
- Design safety surveillance strategies, manage safety signals for development and marketed products, oversee safety data collection, prioritize safety signals, and author or review safety evaluation reports in collaboration with Safety Science.
- Develop and submit Risk Management Plans (RMPs), execute risk management strategies, and collaborate with internal and external stakeholders to ensure effective risk management for assigned products.
- Provide timely, high-quality contributions to periodic and ad hoc safety reports, including authoring and reviewing medical sections and conducting overall medical-scientific analyses.
- Monitor and assess the safety profile of developmental and marketed products, represent PV in study teams, and contribute to the design, conduct, analysis, and reporting of Phase 1–3 clinical trials and Post-Authorization Studies.
Essential Knowledge & Experience:
- Extensive experience in the pharmaceutical industry or a related health science setting.
- Comprehensive expertise in pharmacovigilance functions, with additional exposure to regulatory or clinical development considered an advantage.
- Strong understanding of safety regulations for both marketed and investigational products, with excellent knowledge of regional and global authority requirements, including ICH guidelines.
- Proven ability to influence decisions relating to patient safety and benefit-risk assessment, supported by in-depth regulatory and safety knowledge.
- Effective leadership and communication skills, with experience collaborating across cross-functional teams and managing complex safety-related activities.
Required Qualification:
- Bachelor's degree; advanced professional degree in scientific, health-related field (e.g. PharmD or PhD) strongly preferred (pharmaceutical industry experience in a relevant therapeutic area preferred); or equivalent.
Additional Information:
- This is a permanent, full-time position.
- This position is based in the Netherlands.
- This position follows our hybrid working model. Role requires a blend of home and minimum 2 day per week in our Leiden office. Flexibility may be required in line with business need.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
