Associate Director, Safety Analysis Scientist

Position Overview

Associate Director, Safety Analysis Scientist (AD SAS) – High Wycombe, United Kingdom. Hybrid role: on‑site three days a week. Provides scientific expertise and leads the safety assessment of assigned products.

Key Responsibilities

• Lead safety evaluations, including strategy discussions, data retrieval, data analysis, report writing and revision.
• Ensure high quality safety evaluations and reports with minimal stakeholder comments and revisions.
• Provide input and review of key regulatory or clinical documents.
• Demonstrate leadership in the Safety Management Team (SMT) and support the Medical Safety Officer (MSO).
• Support SMT activities such as preparing and presenting data, compiling meeting minutes, updating signal tracking information.
• Lead proactive safety data reviews and formulate a global safety position for use in aggregate safety reports.
• Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
• Assume responsibility for novel projects, creating value and innovating without defined processes; may seek guidance from Directors for complex projects.
• Lead cross‑functional training of relevant stakeholders.
• Act as product or process subject‑matter expert for audits/inspections.
• Participate in or lead department and/or cross‑functional initiatives.
• Explore innovative ways of presenting data, preparing reports, and improving efficiencies within the programs owned.
• Assist Directors in the creation, review and implementation of controlled documents and other related tools.
• Manage unscheduled reports within the Aggregate Report Calendar.
• Manage activities within smaller therapeutic areas, as applicable.
• Line‑manage contractor positions within the team, as applicable.
• Act as backup to the Therapeutic Area Lead (TAL) as needed.
• Oversight of deliverables prepared by other team members, especially complex reports.

Education & Experience

• Bachelor’s Degree in Healthcare‑related or Biomedical Science (11+ years industry experience or equivalent) – required.
• Advanced Degree in Healthcare‑related or Biomedical Science (8+ years industry experience or equivalent) – preferred.
• Medical writing or Pharmacovigilance experience required.
• Working knowledge of medical concepts and familiarity with safety activities in drug development and post‑marketing, and global safety health authority requirements.
• Clinical experience preferred.
• Oncology experience preferred.

Core Skills & Competencies

• Ability to understand and analyze complex medical‑scientific data.
• Ability to interpret and present complex data to determine benefit‑risk impact.
• Excellent English verbal and written communication skills.
• Ability to interact effectively with stakeholders, including business partners.
• Proven leadership skills and ability to work in a matrix environment.
• Planning and prioritisation to meet deadlines and handle multiple priorities.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Ability to independently influence, negotiate and communicate with internal and external customers.

Additional Skills (Preferred)

• Clinical Operations, Compliance Management, Compliance Risk, Data Reporting, Medicines and Device Development and Regulation, Mentorship, Presentation Design, Quality Control (QC), Research Ethics, Researching, Risk Management, Safety Investigations, Safety‑Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Tactical Planning, Technical Credibility, Technical Writing.

Location & Work Arrangement

High Wycombe, Buckinghamshire, United Kingdom. Hybrid position – on‑site three days a week.

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