At a Glance
- Tasks: Lead safety evaluations and prepare scientific analyses for product safety.
- Company: Dynamic healthcare company focused on innovative safety solutions.
- Benefits: Hybrid working, competitive salary, and opportunities for professional growth.
- Other info: Join a collaborative team and mentor future safety analysis scientists.
- Why this job: Make a real impact in healthcare by ensuring product safety and compliance.
- Qualifications: Bachelor’s in healthcare or biomedical science with extensive industry experience.
The predicted salary is between 60000 - 80000 £ per year.
This hybrid position requires on-site presence three days a week.
Purpose
The Manager SAS provides scientific expertise and leads the safety assessment of assigned products. In partnership with the Medical Safety Officer (MSO), the Manager SAS is responsible for preparing scientific safety analyses and evaluations required for regulatory compliance and safety-related decisions for marketed products and products in development.
Key Responsibilities
- Lead safety evaluations, including strategy discussions, data retrieval, analysis, report writing, and revision.
- Ensure high-quality safety evaluations and reports with minimal-to-moderate stakeholder comments.
- Support AD SASs on novel projects without defined processes.
- Provide input and review to key regulatory or clinical documents as appropriate.
- Demonstrate leadership in the SMT and support the MSO.
- Support SMT activities such as preparing data presentations, compiling meeting minutes, and updating signal tracking information.
- Lead proactive safety data reviews and develop a safety position across GMS for aggregate safety reports.
- Support Health Authority interactions regarding safety and risk management, both written and verbal.
- Contribute to cross-functional training of relevant stakeholders.
- Mentor other SASs on activities within the role.
- Participate in departmental and cross-functional initiatives, exploring innovative ways to present data, prepare reports, and improve efficiencies.
- Assist in creating, reviewing, and implementing controlled documents and other related tools.
- Support audits and inspections.
Qualifications
Education: Bachelor’s Degree in a healthcare-related or biomedical science discipline (minimum 9+ years of industry experience or equivalent). Advanced Degree (healthcare-related or biomedical science) preferred (minimum 6+ years of industry experience or equivalent).
Experience: Working knowledge of medical concepts; familiarity with safety activities in drug development, post-marketing, and global safety health authority requirements; medical writing or PV experience; ability to analyze and interpret complex medical-scientific data; ability to present benefit-risk information; excellent English communication skills; effective stakeholder interaction; proven leadership; ability to plan work, meet deadlines, and handle multiple priorities; proficiency in Microsoft Word, Excel, and PowerPoint; ability to influence, negotiate, and communicate with internal and external customers.
Preferred Experience: Clinical experience.
Required Skills: Business Alignment, Clinical Operations, Coaching, Compliance Management, Compliance Risk, Critical Thinking, Data Reporting, Medicines and Device Development and Regulation, Organizing, Quality Control (QC), Research Ethics, Researching, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Technical Writing.
Manager, Safety Analysis Scientist employer: 7360-Janssen-Cilag Limited Legal Entity
As a Manager, Safety Analysis Scientist at our High Wycombe location, you will thrive in a dynamic hybrid work environment that fosters collaboration and innovation. We prioritise employee growth through mentorship and cross-functional training, ensuring you have the tools to excel in your role while contributing to meaningful safety assessments that impact public health. Our supportive work culture values scientific expertise and encourages proactive engagement, making us an exceptional employer for those seeking a rewarding career in healthcare.
Contact Details:
7360-Janssen-Cilag Limited Legal Entity Recruitment Team
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