Perform cumulative safety data reviews across trials or programs to assess safety profiles and identify emerging risks or trends
Oversee the Safety Surveillance activities, including signal detection, literature reviews, and aggregate safety data analysis using tools like Safety Dashboards, Spotfire, and Elluminate
Collaborate with Safety Physicians to review and align on safety data conclusions for informed decision-making regarding assigned program(s)
Author periodic reports such as DSURs, PSURs, PBRERs, Risk Management Plans (RMPs), and provide input into structured Benefit Risk Assessments (sBRAs)
Provide input into regulatory submissions (e.g., BLA, Module 2.7.4/2.5) and respond to Health Authority queries with scientifically sound responses
Contribute or be the primary safety contact person to/for to clinical trial-related documents including Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Statistical Analysis Plans (SAPs), and eCRF setup
Mentor new team members by providing training on core safety processes and fostering their development within the organization
Act as Subject Matter Expert during audits and inspections for key safety processes such as Safety Surveillance and aggregate report generation

Advanced degree in life sciences/healthcare; PhD in a relevant discipline or post-doctoral pharmacovigilance certification preferred
At least 5 years of experience in clinical research with significant exposure to pharmacovigilance activities within biotech/pharmaceutical industries or CROs
Expert knowledge of pharmacovigilance laws/regulations as well as GCP/GVP guidelines
Proven experience in designing and implementing clinical safety processes/tools and assessing/reporting safety data from clinical trials
Strong communication skills for organizational/scientific matters with an ability to influence through persuasive appearance
Proactive mindset with a solution-oriented attitude; adept at handling ambiguity with a balanced approach
High ethical standards serving as a role model within the organization
Fluency in written and spoken English.

Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre-tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
…and more! More details to be shared.

Associate Director, Safety Scientist

Key skills