Novartis is hiring for the position of External Vigilance Engagements Lead in Hyderabad. The role focuses on pharmacovigilance and/or device vigilance, external business partner agreements, regulatory compliance, alliance management, and transition projects involving mergers and acquisitions, divestments, in-licensing, out-licensing, and other strategic projects.
The position requires 2–5 years of experience in clinical safety, pharmacovigilance, regulatory, or compliance-related areas, along with knowledge of clinical safety reporting, safety databases, and relevant industry regulations.
Job Details
| Details | Information |
|---|---|
| Company | Novartis |
| Position | External Vigilance Engagements Lead |
| Location | Hyderabad, India |
| Work Type | Full Time |
| Experience | 2–5 years |
| Job Type | Pharmacovigilance / Clinical Safety |
| Requisition ID | REQ-10088191 |
| Application Deadline | October 9, 2026 |
Position
External Vigilance Engagements Lead
The role provides expertise and cross-functional leadership for Novartis Enterprise contractual arrangements involving pharmacovigilance and/or device vigilance, including Global and Local Vigilance Agreements and Clinical Trial Supply Agreements.
The position also supports the transition of vigilance systems and processes for medical devices and diagnostic portfolios during mergers, acquisitions, divestments, in-licensing, out-licensing, and other strategic projects.
Responsibilities
- Provide expertise on current and developing pharmacovigilance and/or device vigilance regulations and guidelines.
- Participate in Vigilance Agreement Partner Risk Assessment (VAPRA) activities for new deals.
- Lead negotiations for assigned vigilance agreements with external business partners.
- Maintain relationships with key external customers and internal stakeholders.
- Ensure compliance with vigilance agreements and transition project plans.
- Lead assigned high-priority transition projects within PS&PV.
- Coordinate project teams and monitor project goals, milestones, and deliverables.
- Identify and escalate potential disruptions to transition project plans.
- Support corrective actions related to compliance and reconciliation issues.
- Assist with training on Novartis pharmacovigilance standards and procedures.
- Represent External Vigilance Engagements in internal and external meetings.
- Support audits and regulatory inspections involving Novartis, external business partners, and transition projects.
Eligibility / Qualifications
Candidates should have:
- A degree in Biomedical Science or a related scientific discipline.
- A higher degree is desirable.
- 2–5 years of experience in clinical safety, pharmacovigilance, regulatory, or compliance-related areas.
- Thorough knowledge of clinical safety reporting requirements and clinical safety databases.
- Current knowledge of industry regulations and guidelines related to pharmacovigilance and/or device vigilance.
- Clinical trial safety experience is preferred.
- Experience with vigilance agreements, partner management, or transition projects is advantageous.
- Ability to work effectively in matrix cross-functional environments.
Required Skills
Pharmacovigilance, Safety Science, Employee Training, Waterfall Model, Clinical Safety Reporting, Safety Databases, Regulatory Compliance, Negotiation, Problem Solving, Cross-Functional Collaboration, Partner Management
Application Details
Location: Hyderabad, India
Work Type: Full Time
Last Date to Apply: October 9, 2026
Requisition ID: REQ-10088191
