Drug Safety Scientist, Global Pharmacovigilance

The Drug Safety Scientist is a member of the Drug Safety & Risk Management (DS&RM) team, supporting proactive safety surveillance and risk management activities. The Drug Safety Scientist performs pharmacovigilance activities and prepares high-quality, submission-ready regulatory and safety documents within established timelines and in compliance with GE HealthCare business requirements, standard operating procedures, and applicable global and local regulatory requirements. The role provides scientific support to Medical Directors for the assessment of safety data from clinical trials and post-marketing experience and supports the EU QPPV in maintaining inspection readiness. Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents including aggregate reports (including PSURs/PBRERs, PADERs, IND-related reports, and DSURs). The Drug Safety Scientist partners closely with Medical Directors, the QPPV, internal cross-functional stakeholders, and external vendors to ensure timely and effective delivery of safety surveillance and risk management activities.,

• Performs safety signal detection and evaluation using safety data and analytical tools to identify and assess potential signals, authors safety review documentation, and partners with cross-functional Safety Review Teams to develop data-driven recommendations and actions.
• Apply data analytics and visualization tools to create and interpret trending analyses, investigate significant changes in reporting patterns, and communicate actionable safety insights
• Authors, reviews, and coordinates high-quality safety content for clinical development and post-marketing regulatory documents, including clinical study protocols, DSURs, RMPs, Safety
• Management Plans, clinical study reports, PSURs/PBRERs, and medical expert statements.
• Gathers, analyzes, and evaluates relevant scientific and safety information to support the development and maintenance of reference safety information within Company Core Documents, including the CCDS and CCSI.
• Collaborates with PV Scientists and Medical Directors 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 within agreed time frames.
• Performs Medical Reviewer of Individual Case Safety Reports.
• Serves as a Subject Matter Expert (SME) for Global Pharmacovigilance and cross-functional teams on applicable ICH, EU, US, and other international clinical and post-marketing safety regulations, guidelines, and product-specific safety information.
• Other activities, special projects and assignments may be assigned where required. As a result, the percentage of time spent across roles for which the employee is responsible for or assisting others will vary depending on project assignments and the requirements within the department.
• Assist in creating and maintaining standard operating procedures and working practices to ensure inspection readiness and compliance with regulations and guidelines.
  
  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 service provider will be considered.
Highest Level of Education achieved :
• Bachelor's or Master's degree in Life Sciences, Biological Sciences, Business/Data Analytics, Pharmacy, Nursing, or a related healthcare discipline.
Required Competence/Work Experience/Skills:
• 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)
Preferred Competence/Work Experience/Skills:
• 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.
Personal Skills:
• 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.
  
  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.