Safety Signal Lead / Safety Signal Expert – Hyderabad, India
Location: Hyderabad (Office), India
Job ID: REQ-10058572
Job Type: Full-Time | Regular
Division: Development | Novartis Healthcare Private Limited
Business Unit: Innovative Medicines
Salary:
Estimated Range: ₹28 – ₹42 LPA
(Based on experience in drug safety, regulatory knowledge, and data analytics. Final compensation will depend on qualifications and internal benchmarking.)
Position Overview:
As a Safety Signal Lead / Expert, you will play a pivotal role in postmarketing pharmacovigilance, leading early signal detection and analysis for a complex portfolio of Novartis products. This highly analytical and strategic position calls for deep medical knowledge, data-driven thinking, and cross-functional collaboration to ensure patient safety while supporting regulatory compliance and innovation.
Key Responsibilities:
Lead signal detection and triage activities using postmarketing spontaneous reporting databases (e.g., FAERS, VigiBase).
Conduct detailed evaluation of single case reports and aggregated safety data to identify new safety signals.
Act as an expert voice in safety evaluations during Product Safety Team (PST) and SMT/SMB meetings.
Perform and validate signal detection through Health Authority database searches and summarize key findings.
Serve as Subject Matter Expert (SME) for automated signal detection methods, guiding safety leads and SMTs.
Respond to Health Authority queries, contribute to regulatory safety documentation, and risk mitigation plans.
Mentor and train junior colleagues, and contribute to development of SOPs and guidance documents.
Monitor Eudravigilance data and ensure timely execution of safety analyses and reporting.
Key Performance Indicators (KPIs):
Timeliness and quality of safety signal analyses and documentation
Regulatory and procedural compliance
Contribution to process improvement and signal detection methodology
Quality of collaboration across Safety, Regulatory, and Clinical teams
Minimum Qualifications:
Medical Degree (MBBS or MD) is mandatory; specialization preferred
Minimum 4 years of experience in drug development, including at least 2 years in patient safety or pharmacovigilance
Deep knowledge of clinical trials, pharmacovigilance regulations, signal detection methodology, and safety science
Proven experience in literature review, aggregate safety report writing, and regulatory compliance
Strong analytical, communication, and documentation skills
Fluency in English (written and spoken)
Preferred Skills:
Hands-on experience with FAERS, Eudravigilance, or Vigibase databases
Familiarity with automated signal detection tools and methodologies
Strong mentorship skills and ability to lead internal safety discussions
Exposure to safety documentation for both regulatory and internal governance
Why Join Novartis?
Novartis fosters a bold, science-driven culture where innovation, collaboration, and patient-centric thinking drive life-changing impact. If you’re ready to lead safety innovation in one of the world’s top pharma companies, this is your calling.
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