Manager, Safety Analysis Scientist

Job Title and Location

Manager, Safety Analysis Scientist (SAS) - High Wycombe, Buckinghamshire, United Kingdom

Hybrid Working

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.