General Information
Job Advert Title Pharmacovigilance Scientist Location Poland, United Kingdom Function/Business Area Quality Employment Class PermanentDescription
Pharmacovigilance ScientistAbout Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focusing 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 a Pharmacovigilance Scientist (PVS), you will manage safety surveillance and signal detection efforts for Astellas products. You will lead the development and implementation of safety strategies, work with internal teams and vendors, and ensure the timely delivery of safety reports for health authorities.
Hybrid Working:
At Astellas, we recognize that our employees enjoy having a balance between their professional and personal lives. We are proud of our hybrid approach, which empowers you to have flexibility on whether to work from home or in the office.
Key Activities:
- Manage signal detection and safety evaluations for Astellas products.
- Provide input and leadership in safety surveillance strategy development.
- Lead safety report preparation, including PSUR, DSUR, and PADER.
- Build collaborative relationships with internal and external stakeholders.
- Lead mentoring and training initiatives for junior team members.
Essential Knowledge & Experience:
- Extensive experience in pharmacovigilance, signal detection, and risk management.
- Proven ability to work effectively in global, cross-functional teams and matrixed environments.
- Strong knowledge of ICH/FDA regulations and drug safety guidelines.
- Proven proficiency in pharmacovigilance reporting systems and MS Office tools (Word, Excel, PowerPoint).
- Strong written and verbal communication skills in a global environment.
- Fluent in written and spoken business English.
Education:
- Bachelor’s degree or equivalent.
Additional information:
- This is a permanent full-time position.
- This position is based in United Kingdom or Poland.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in the United Kingdom or Poland office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
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.
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