Safety Signal Expert
Job ID: REQ-10058572
Location: Hyderabad, India
Division: Development
Business Unit: Innovative Medicines
Site: Hyderabad (Office)
Company / Legal Entity: Novartis Healthcare Private Limited (IN10)
Functional Area: Research & Development
Job Type: Full-time, Regular
Shift Work: No
Job Summary
The Safety Signal Expert provides robust safety evaluation and medical expertise to ensure optimal patient safety for assigned compounds. This role focuses on early detection of safety signals from internal and external spontaneous reporting databases and provides expert evaluation for regulatory and cross-functional teams.
Key Responsibilities
Safety Signal Detection & Management:
Lead safety signal detection and triage for assigned product portfolio.
Identify new safety signals early through review and medical evaluation of technical hits in postmarketing databases.
Analyze single case reports and aggregate data.
Provide expert input for postmarketing signal detection activities during Product Safety Team, SMT/SMB, and Joint Safety Committee meetings.
Act as Subject Matter Expert (SME) for postmarketing Safety Signal Detection and guide cross-functional teams on methodology.
Perform database searches in Health Authority databases (e.g., FAERS, Vigibase) and report results.
Manage Eudravigilance database requests and monitor assigned products.
Perform QC checks on database searches performed by colleagues.
Collaboration & Communication:
Collaborate with product safety leads and cross-functional teams to provide expert input.
Contribute to MSRB presentations and other safety documentation.
Provide safety input for ad hoc Health Authority queries.
Training & Process Improvement:
Mentor and train junior Safety Signal colleagues.
Participate in medical safety onboarding activities.
Contribute to development and updates of SOPs and business guidance documents.
Drive enhancements and new approaches for automated signal detection in internal/external databases.
Key Performance Indicators
Timeliness and quality of safety analyses, interpretations, and presentations.
Compliance with internal and external regulations and procedures.
Ability to work effectively in a metrics-driven organization.
Minimum Requirements
Education:
Medical Degree (MBBS or MD) required.
Specialization in medical field preferred.
Experience:
At least 4 years in drug development in a major pharmaceutical company.
Minimum 2 years in patient safety at an operational or medical position (or equivalent).
Experience in Quantitative Safety Signal Detection and Safety Signal Management.
Knowledge of clinical trial methodology, regulatory requirements, statistics, and publication writing.
Proven ability to analyze, interpret, and present safety information in writing and orally.
Skills:
Aggregate review and literature review.
Pharmacovigilance and regulatory compliance.
Safety science expertise.
Languages:
English (fluent)
Why Novartis
Novartis is committed to improving patients’ lives by fostering a community of smart, passionate professionals. Employees are encouraged to collaborate, innovate, and create breakthroughs that change lives. Novartis provides a supportive and inclusive environment, with benefits and resources to help employees thrive personally and professionally.
Accessibility & Accommodation:
Novartis provides reasonable accommodations for individuals with disabilities. Requests can be sent to: diversityandincl.india@novartis.com (include job requisition number).
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