Associate Director, Safety Analysis Scientist

Role Overview

• Lead safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision
• Ensure high quality safety evaluations and reports with minimal comments from stakeholders and minimal revisions required
• Provide input and review of key regulatory or clinical documents as appropriate
• Demonstrate leadership in the SMT and support the MSO
• Support SMT activities (e.g., preparing and presenting data, compiling meeting minutes, updating signal tracking information)
• Lead proactive safety data reviews, if applicable and form a safety position across Global Medical Safety (GMS) which can be leveraged for aggregate safety reports
• Provide support for Health Authority interactions regarding safety and risk management, both written and verbal
• Assume responsibility for novel projects, create value and innovate without defined processes
• May seek guidance from Directors (i.e., SAS TAL) for complex projects
• Lead cross-functional training of relevant stakeholders
• Act as product or process Subject Matter Expert (SME) 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 they own
• Assist Directors in the creation, review and implementation of controlled documents and other related tools
• Management of unscheduled reports within the Aggregate Report Calendar
• Management activities within smaller Therapeutic Areas, as applicable
• Line-management of contractor positions within the team, as applicable
• Act as backup to TAL as needed (e.g., Director SAS TAL is unavailable)
• Oversight of deliverables by other team members (e.g., complex reports), as needed

Requirements

• Bachelor’s Degree Required: Healthcare-related or Biomedical Science (11+ years industry experience or equivalent)
• Advanced Degree Preferred: Healthcare-related or Biomedical Science (8+ years industry experience or equivalent)
• Medical writing or Pharmacovigilance (PV) experience required
• Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements
• Ability to understand and analyze complex medical-scientific data from a broad range of disciplines
• Ability to interpret and present complex data to determine benefit-risk impact
• Excellent English verbal and written communication skills
• Ability to effectively interact with stakeholders, including business partners
• Ability to work in a matrix environment, proven leadership skills
• Ability to plan work to meet deadlines and effectively handle multiple priorities
• Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint)
• Ability to independently influence, negotiate and communicate with both internal and external customers

Benefits

• medical insurance
• dental insurance
• vision insurance
• life insurance
• short
• and long-term disability
• business accident insurance
• group legal insurance
• retirement plan (pension)
• savings plan (401(k))
• vacation up to 120 hours
• sick time up to 40 hours
• holiday pay including floating holidays up to 13 days