Safety Signal Lead / Safety Signal Expert
REQ-10058572
Hyderabad, India
Hyderabad (Office)
Development
Innovative Medicines
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Research & Development
Full-time | Regular
No
August 01, 2025
In collaboration with the Global Program Safety Lead (GPSL), the Safety Signal Lead/Expert provides high-level safety evaluation expertise to ensure optimal patient safety for assigned compounds. The role focuses on early identification and evaluation of safety signals using both internal and external postmarketing spontaneous reporting databases.
Lead safety signal detection and triage activities for a complex product portfolio.
Identify new safety signals through in-depth medical evaluation of postmarketing data, individual case reports, and aggregate analysis.
Conduct searches and analyses in external Health Authority databases (e.g., FAERS, Vigibase).
Perform quality checks (QC) on Health Authority database searches conducted by colleagues.
Present safety signal evaluation results in cross-functional meetings (e.g., Product Safety Team, SMT/SMB, Joint Safety Committees).
Serve as an expert member in cross-functional Safety Management Teams.
Contribute safety insights to safety-related documents, MSRB presentations, and regulatory responses.
Provide feedback for improvements to existing tools and processes for safety signal detection.
Contribute to development of automated signal detection approaches in internal/external databases.
Manage Eudravigilance database monitoring for assigned products.
Support safety documentation efforts including risk management plans, safety summaries, and HA responses.
Mentor and train junior safety signal detection staff.
Drive onboarding for new medical safety associates.
Lead updates of SOPs and business guidance documents.
Timely and high-quality safety analyses and presentations.
Compliance with regulatory and internal standards.
Effective collaboration and delivery within a metric-driven environment.
Medical Degree (MBBS or MD) required
Specialization preferred
Relevant post-graduation experience (e.g., clinical or postdoctoral)
Minimum 4 years in drug development in the pharmaceutical industry
Including 2 years in patient safety (medical or operational)
Proven experience with:
Quantitative safety signal detection and management
Regulatory submissions and safety documents
Clinical trial methodologies, scientific analysis, and statistics
Signal detection and management
Aggregate data review
Literature review
Safety science and pharmacovigilance
Regulatory compliance
Issue management
Strong analytical and communication skills
Fluency in English (required)
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