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About the Role
The Drug Safety Scientist supports proactive safety surveillance and risk management activities within the Drug Safety & Risk Management (DS&RM) team. This role performs pharmacovigilance activities and prepares high-quality, submission-ready regulatory and safety documents in compliance with business requirements and regulatory standards. The position provides scientific support for safety data assessment from clinical trials and post-marketing experience, and assists the EU QPPV in maintaining inspection readiness.
Responsibilities
- Performs safety signal detection and evaluation using safety data and analytical tools.
- Authors safety review documentation and partners with cross-functional Safety Review Teams.
- Applies data analytics and visualization tools to create and interpret trending analyses.
- Communicates actionable safety insights.
- Authors, reviews, and coordinates safety content for regulatory documents, including clinical study protocols, DSURs, RMPs, Safety Management Plans, clinical study reports, PSURs/PBRERs, and medical expert statements.
- Gathers, analyzes, and evaluates scientific and safety information to support reference safety information.
- Collaborates to provide scientific and medical input to responses to safety-related questions from regulatory authorities.
- Prepares or facilitates writing of accurate, medically sound, and submission-ready statements, safety assessments, and benefit-risk evaluations.
- Performs Medical Reviewer of Individual Case Safety Reports.
- Serves as a Subject Matter Expert (SME) for Global Pharmacovigilance and cross-functional teams on ICH, EU, US, and other international safety regulations and guidelines.
- Assists in creating and maintaining standard operating procedures and working practices for inspection readiness and regulatory compliance.
Requirements
- Experience in drug safety risk management and pharmacovigilance (safety signal detection, data mining techniques, preparation risk management plans, aggregate reports and company core safety information).
- Relevant experience in clinical development or medical affairs in industry or with a service provider will be considered.
- Working knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing pharmacovigilance.
- Minimum of 3+ years of validated experience working in safety &/or scientific activities in at least 3 of the following areas: Post-Marketing Surveillance (including signal detection & evaluation), Periodic Safety Reports (deliver strategy, preparation and authoring), DSURs, INDs, including data analysis.
- Knowledge of safety systems (Argus & Veeva).
- Good medical writing skills and ability to analyse safety data.
- Good communication skills.
- Good knowledge of PV regulations.
- Strong ability to leverage AI and emerging digital tools to improve data analysis, automation, and operational efficiency.
- Strong organizational and prioritization skills, with the ability to manage multiple competing priorities while maintaining quality and meeting deadlines.
- Proactive self-starter who demonstrates initiative, works effectively with a high degree of independence, and contributes collaboratively within a team environment.
Skills
- Safety signal detection
- Data mining techniques
- Risk management plans preparation
- Aggregate reports preparation
- Company core safety information preparation
- Data analytics
- Data visualization
- Medical writing
- Safety data analysis
- Communication
- PV regulations knowledge
- AI and emerging digital tools utilization
- Organizational skills
- Prioritization skills
- Team collaboration
Location
- Remote
Work Type
- Full-time
Experience Level
- Minimum of 3+ years of validated experience
Education Level
- Bachelor’s or Master’s degree in Life Sciences, Biological Sciences, Business/Data Analytics, Pharmacy, Nursing, or a related healthcare discipline.
Benefits
- Total rewards designed to unlock ambition
- Flexibility
- Salary and benefits expected from an organization with global strength and scale
- Career opportunities
- Culture that fosters care, collaboration and support
About the Company
- GE Healthcare is a leading global medical technology and digital solutions innovator.
- Our mission is to improve lives in the moments that matter.
- Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Equal Opportunity
- GE Healthcare is an Equal Opportunity Employer where inclusion matters.
- Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
- We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.