General Information
Job Advert Title Senior Manager Strategy and Planning Location United Kingdom Function/Business Area Regulatory Affairs and Pharmacovigilance Employment Class PermanentDescription
Regulatory Affairs & Pharmacovigilance StrategistAbout 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 a member of the Pharmacovigilance (PV) Reporting and Information Management Team, you will play a pivotal role in ensuring operational excellence in global PV systems and business operations. As the Team Lead, you will leverage your expertise to align business needs with technological advancements, driving improvements and maintaining excellence in PV Information Management. Your contributions will directly support our mission to advance patient care through innovative therapies, shaping the future of healthcare.
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:
- Lead the development and maintenance of a long-term reporting strategy to support various PV activities.
- Ensure timely delivery of high-quality outputs from PV IT systems to meet business needs.
- Collaborate with crossfunctional teams to design optimal approaches for data analysis and validation strategies.
- Oversee the management and improvement of reports from PV IT systems, ensuring compliance with global regulatory requirements.
- Provide leadership and mentorship to the RIM team, fostering a high-performing and collaborative environment.
Essential Knowledge & Experience:
- Develop and maintain a long-term reporting strategy to support various PV activities.
- Ensure PV IT systems consistently deliver high-quality outputs that align with business needs.
- Collaborate with cross-functional teams to design optimal approaches for data analysis and validation strategies.
- Oversee the management and enhancement of reports from PV IT systems, ensuring compliance with global regulatory requirements.
- Provide leadership and mentorship to the RIM team, fostering a high-performing and collaborative environment.
Preferred Experience:
- Familiarity with regulations pertaining to adverse event reporting.
- Experience in vendor management and personnel management.
- Advanced skills in Microsoft Office and safety database configurations.
Education/Qualification:
- BA/BS in a computer-related field or higher education in a healthcare discipline, or equivalent.
Additional Information:
- This is a full-time, permanent role.
- 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 local 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.
#LI-Addlestone#Hybrid#LI-JU1
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