Associate Director – Safety Analysis Scientist
OneTrust
full-time
Posted on:
Location Type: Hybrid
Location: Horsham • New Jersey • Pennsylvania • United States
Visit company websiteExplore more
Salary
💰 $137,000 - $235,750 per year
Job Level
About the role
- Provides scientific expertise and leads the safety assessment of assigned products.
- Prepares scientific safety analysis and evaluations for regulatory compliance.
- Supports product Safety Management Teams (SMTs).
- Collaborates with cross-functional safety partners to determine a product’s safety strategy.
- Completes safety analyses and evaluations, proactively reviews safety data.
- Leads safety data review meetings and interprets safety information.
- Provides input and review of key regulatory or clinical documents as appropriate.
- Demonstrates leadership in the SMT and supports the MSO.
- Manages unscheduled reports within the Aggregate Report Calendar.
- Acts as product or process Subject Matter Expert (SME) for audits/inspections.
- Participates in, or leads, department and/or cross-functional initiatives.
Requirements
- A minimum of a Bachelor’s degree in Biomedical Science or a Healthcare related field is required.
- An advanced degree is preferred.
- 8+ years of relevant experience is required.
- Medical writing or Pharmacovigilance (PV) experience is required.
- Working knowledge of medical concepts and familiarity with safety activities in drug development and post-marketing and global safety health authority requirements is required.
- Ability to understand and analyze complex medical-scientific data from a broad range of fields is required.
- Ability to interpret and present complex data to determine benefit-risk impact is required.
- Excellent English verbal and written communication skills is required.
- Ability to plan work to meet deadlines and effectively balance multiple priorities is required.
- Ability to effectively interact with team members, including business partners is preferred.
- Ability to work in a matrix environment, proven leadership skills is preferred.
- Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint) is preferred.
- Ability to independently influence, negotiate and communicate with both internal and external customers is preferred.
- Clinical experience is preferred.
Benefits
- medical insurance
- dental insurance
- vision insurance
- life insurance
- short-term disability
- long-term disability
- business accident insurance
- group legal insurance
- pension plan
- 401(k) savings plan
- vacation – 120 hours per calendar year
- sick time - 40 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
- holiday pay, including floating holidays – 13 days per calendar year
- work, personal and family time - up to 40 hours per calendar year
- parental leave – 480 hours within one year of the birth/adoption/foster care of a child
- condolence leave – 30 days for an immediate family member: 5 days for an extended family member
- caregiver leave – 10 days
- volunteer leave – 4 days
- military spouse time-off – 80 hours
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingpharmacovigilancesafety analysissafety evaluationdata interpretationregulatory complianceclinical document reviewsafety data reviewmedical-scientific data analysisbenefit-risk analysis
Soft Skills
leadershipcommunicationplanningprioritizationteam collaborationinfluencenegotiationpresentationinterpersonal skillsmatrix environment adaptability