GE HealthCare is inviting applications for the position of Drug Safety Scientist – Global Pharmacovigilance. The role is part of the Drug Safety & Risk Management (DS&RM) team and focuses on pharmacovigilance activities, safety signal detection, risk management, aggregate safety reporting, and regulatory document preparation.
The selected candidate will support proactive safety surveillance, evaluate clinical trial and post-marketing safety data, prepare submission-ready regulatory documents, and collaborate with Medical Directors, the EU Qualified Person Responsible for Pharmacovigilance (QPPV), and cross-functional teams.
Candidates with a Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biological Sciences, Business/Data Analytics, Nursing, or a related healthcare discipline can apply. A minimum of 3 years of validated experience across at least three specified safety or scientific activity areas is required.
Job Details
| Particulars | Details |
|---|---|
| Company | GE HealthCare |
| Job Title | Drug Safety Scientist – Global Pharmacovigilance |
| Department | Drug Safety & Risk Management (DS&RM) |
| Job Category | Pharmacovigilance / Drug Safety |
| Location | Bengaluru, London, Oslo |
| Bengaluru Office | Kalyani Platina, Magnolia |
| Job Type | Full Time |
| Experience | Minimum 3+ years |
| Qualification | Bachelor’s or Master’s degree |
| Requisition ID | R4048890 |
Position
Drug Safety Scientist – Global Pharmacovigilance
The position involves scientific assessment of safety information from clinical trials and post-marketing experience, safety signal evaluation, preparation of aggregate safety reports, and maintenance of pharmacovigilance compliance and inspection readiness.
Job Responsibilities
Selected candidates will be responsible for the following activities:
- Perform safety signal detection and evaluation using safety data and analytical tools to identify potential safety signals.
- Prepare safety review documentation and collaborate with cross-functional Safety Review Teams to develop recommendations.
- Apply data analytics and visualization tools to perform trending analyses and investigate changes in safety reporting patterns.
- Author, review, and coordinate safety content for clinical development and post-marketing regulatory documents.
- Prepare aggregate safety reports, including DSURs, PSURs/PBRERs, PADERs, and IND-related reports.
- Support the preparation of Risk Management Plans (RMPs), Safety Management Plans, clinical study protocols, clinical study reports, and medical expert statements.
- Gather and evaluate scientific and safety information to maintain reference safety information in Company Core Documents, including CCDS and CCSI.
- Collaborate with PV Scientists and Medical Directors to prepare responses to safety-related regulatory authority questions.
- Prepare medically sound safety assessments, benefit-risk evaluations, and submission-ready statements.
- Perform medical review of Individual Case Safety Reports (ICSRs).
- Provide subject matter expertise on applicable ICH, EU, US, and other international pharmacovigilance regulations and guidelines.
- Assist in creating and maintaining standard operating procedures and working practices to support regulatory compliance and inspection readiness.
Eligibility Criteria and Qualifications
Candidates applying for the GE HealthCare Drug Safety Scientist position should meet the following requirements:
Educational Qualifications:
A Bachelor’s or Master’s degree in any of the following disciplines:
- Pharmacy
- Life Sciences
- Biological Sciences
- Business/Data Analytics
- Nursing
- Related healthcare disciplines
Work Experience:
- Minimum of 3+ years of validated experience in safety and/or scientific activities across at least three of the following areas:
- Post-Marketing Surveillance, including safety signal detection and evaluation.
- Periodic Safety Reports, including strategy, preparation, and authoring.
- Development Safety Update Reports (DSURs).
- Investigational New Drug (IND) activities, including data analysis.
- Experience in drug safety risk management and pharmacovigilance.
- Experience in clinical development or medical affairs within the industry or a service provider will also be considered.
Required Skills and Competencies
Applicants should have the following technical knowledge and professional skills:
- Working knowledge of FDA, EU, and ICH pharmacovigilance guidelines, initiatives, and regulations.
- Knowledge of safety signal detection and data mining techniques.
- Experience preparing Risk Management Plans and aggregate safety reports.
- Knowledge of Company Core Safety Information.
- Familiarity with safety databases and systems such as Argus and Veeva.
- Ability to analyse safety data and prepare medical and regulatory documents.
- Good medical writing and communication skills.
- Strong understanding of pharmacovigilance regulations.
- Ability to leverage AI and emerging digital tools for data analysis, automation, and operational efficiency.
Personal Skills:
- Strong organizational and prioritization abilities.
- Ability to manage multiple competing priorities while meeting deadlines.
- Proactive approach and initiative.
- Ability to work independently and collaboratively within a team.
Application Details
| Particulars | Details |
|---|---|
| Company | GE HealthCare |
| Position | Drug Safety Scientist – Global Pharmacovigilance |
| Location | Bengaluru, Karnataka |
| Employment Type | Full Time |
| Requisition ID | R4048890 |
