Lead Safety Science Specialist
Company
Fortrea – A global clinical research and pharmacovigilance organization providing clinical safety, post-marketing surveillance, and regulatory reporting services to support patient safety and drug development.
Job Details
Job Title: Lead Safety Science Specialist
Job Requisition ID: 262138
Employment Type: Full-time
Location: Bangalore, India (Hybrid)
Application Deadline: June 30, 2026
About the Role
The Lead Safety Science Specialist is responsible for managing pharmacovigilance (PV) and clinical safety operations, including adverse event processing, safety reporting, regulatory submissions, and quality oversight.
This role ensures timely and compliant safety reporting to clients and regulatory authorities while supporting global pharmacovigilance systems and study teams.
Key Responsibilities
1. Adverse Event Processing & Case Management
Receive, review, and process adverse event (AE) reports from:
Clinical trials (solicited reports)
Post-marketing sources (spontaneous reports)
Perform:
Case entry into safety databases
AE coding and narrative writing
Follow-up for missing or incomplete information
Assess cases against product labeling (if applicable)
2. Regulatory Safety Reporting
Submit expedited Serious Adverse Event (SAE) reports to:
Regulatory authorities
Ethics Committees
Sponsors and investigators
Third-party vendors and partners
Ensure submissions meet required global timelines.
3. Aggregate & Periodic Safety Reporting
Prepare and support submission of:
Individual Case Safety Reports (ICSRs)
Annual IND reports
Development Safety Update Reports (DSURs)
European Annual Safety Reports (ASRs)
Periodic line listings and aggregate safety reports
4. Quality Review & Compliance
Perform peer or independent QC of safety reports.
Ensure adherence to:
SOPs and Work Instructions
ICH guidelines
Good Clinical Practice (GCP)
Support audit and inspection readiness activities.
5. Safety Systems & Data Reconciliation
Work with data management teams for safety database reconciliation.
Maintain understanding of safety database conventions.
Ensure data consistency across systems.
6. Signal Detection & Safety Monitoring
Assist in:
Signal detection activities
Trend and pattern recognition in safety data
Monitor workflow timelines and ensure compliance.
7. Team Support & Leadership
Support and train junior safety staff.
Provide guidance on case handling and reporting processes.
Assist in SOP and Work Instruction development.
8. Stakeholder Collaboration
Participate in project and client meetings.
Communicate with:
Sponsors
Regulatory teams
Internal functional groups
Contribute to cross-functional safety discussions.
9. Safety Planning & Documentation
Support development of:
Safety Management Plans (SMPs)
Reconciliation Plans
Other safety documentation (under supervision)
Required Qualifications
Education (Any ONE)
Non-degree + 2–3 years safety experience OR 5 years relevant experience
Associate degree + 2–3 years safety experience OR 4 years relevant experience
Bachelor’s degree (Life Sciences or related) + 2 years safety experience OR 3–4 years experience
Master’s degree + 2 years safety experience OR 2–3 years experience
PharmD + 2 years experience (residency/fellowship may be considered)
Required Skills & Knowledge
Technical Knowledge
Strong understanding of:
Pharmacovigilance processes
Adverse event reporting
ICH guidelines
Good Clinical Practice (GCP)
Global regulatory safety requirements
Knowledge of medical device reporting (preferred)
Core Skills
Strong attention to detail and accuracy
Good analytical and problem-solving skills
Ability to work independently with minimal supervision
Strong teamwork and collaboration abilities
Ability to handle multiple priorities under deadlines
Strong communication and presentation skills
Additional Competencies
Ability to interpret safety data and identify trends
Ability to influence stakeholders at operational and managerial levels
Strong documentation and reporting skills
Work Environment
Office-based or hybrid work model
Collaborative pharmacovigilance operations environment
May involve interaction with global teams and clients
Inclusion & Accessibility
Fortrea is committed to equal opportunity employment and maintaining an inclusive workplace.
Reasonable accommodations are available during the recruitment process upon request.
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Remote, India | Siliguri |Illinois :
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Sheffield |Oxfordshire :
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Canada |Quebec :
Montreal |Brussels :
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Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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Manila |Croatia :
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Prague |Chile :
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