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.
Lead cross-functional training of relevant stakeholders.
Act as product or process Subject Matter Expert (SME) for audits/inspections.

Bachelor’s Degree required in Healthcare-related or Biomedical Science (11+ years industry experience or equivalent).
Advanced Degree preferred in 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.
Excellent English verbal and written communication skills.
Ability to effectively interact with stakeholders, including business partners.
Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint).

Medical
Dental
Vision
Life insurance
Short
and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – up to 120 hours per calendar year
Sick time
up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time
up to 40 hours per calendar year

Associate Director – Safety Analysis Scientist

Key skills