General Information
Job Advert Title Global Aggregate Safety Analyst, Senior Manager, Aggregate Report Location United Kingdom Function/Business Area Regulatory Affairs and Pharmacovigilance Employment Class PermanentDescription
Global Aggregate Safety Analyst, Senior Manager, Aggregate ReportAbout Astellas:
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
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 have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
The Opportunity:
As an Aggregate Safety Analyst at Astellas Pharma, this role plays a critical part in ensuring the safety of both developmental and marketed products. Reporting to the Global Team Lead for Aggregate Safety Analysis, the analyst supports the development of high-quality periodic safety reports and contributes to the execution of global safety strategies. Their expertise and attention to detail help strengthen pharmacovigilance operations, directly impacting patient care and reinforcing Astellas' commitment to excellence in drug safety.
You will be part of an inclusive team that works to develop innovative therapies for patients.
Hybrid Working:
At Astellas, we recognise that our employees enjoy having a 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.
Key Activities for this role:
- Prepare accurate, high-quality, and timely periodic safety reports in compliance with global regulatory requirements.
- Execute ASA-specific objectives within the global Safety Science and Labelling strategy.
- Support the oversight of worldwide ASA activities to ensure timely and high-quality deliverables.
- Provide expert guidance to medical writers and other contributors on safety data collection and analysis.
- Stay informed on evolving regulations related to periodic safety reporting and assess their impact on business processes.
Essential Knowledge & Experience:
- Extensive experience in the health sciences industry, including at least two years in pharmacovigilance.
- Comprehensive knowledge of global pharmacovigilance regulations and guidelines (US, ICH, EU).
- Exceptional communication skills in English, both verbal and written, with a strong global perspective.
- Proven ability to solve complex problems and manage multiple projects efficiently.
- Strong attention to detail, delivering high-quality documents under pressure.
Preferred Experience:
- Experience working in a global or cross-cultural environment.
- Familiarity with pharmacovigilance databases and reporting outputs.
- Advanced degrees in Science or Medical fields (PhD, MS, Pharm.D, MD, RN) are advantageous.
Educations/Qualifications:
- A postgraduate Science or Medical degree or bachelor’s degree in a healthcare field, or equivalent.
Additional Information:
- This is a permanent, full-time position.
- Location: UK office (Addlestone).
- This position follows our hybrid working model. The role requires a blend of home and minimum 1 day per quarter in our Addlestone office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
What We Offer:
- A challenging and diversified job in an international setting.
- Opportunity and support for continuous development.
- Inspiring work climate.
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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