Novartis has announced an opening for the position of External Vigilance Engagements Lead at its Hyderabad office. This is a full-time opportunity for candidates with experience in Pharmacovigilance, Clinical Safety, Regulatory Compliance or Device Vigilance.
The selected candidate will work on vigilance agreements, external partner management, regulatory compliance, transition projects, audits and cross-functional pharmacovigilance activities.
Job Details
| Particulars | Details |
|---|---|
| Company | Novartis |
| Job Title | External Vigilance Engagements Lead |
| Job Location | Hyderabad, Telangana |
| Employment Type | Full Time |
| Experience | 2–5 Years |
| Qualification | Degree in Biomedical Science or related scientific discipline |
| Job ID | REQ-10088191 |
| Last Date to Apply | October 9, 2026 |
Job Description
The External Vigilance Engagements Lead will provide expertise and cross-functional leadership in pharmacovigilance and/or device vigilance for assigned Novartis enterprise contractual arrangements.
The role will also support the transition of vigilance systems and processes associated with mergers and acquisitions, divestments, in-licensing, out-licensing and other strategic projects.
The position involves working with internal Novartis teams and external business partners to maintain regulatory compliance and effective vigilance processes.
Key Responsibilities
- Maintain knowledge of current and developing regulations and guidelines related to pharmacovigilance and device vigilance.
- Provide pharmacovigilance expertise and advice to internal teams and external business partners.
- Participate in Vigilance Agreement and Partner Risk Assessment activities for new business deals.
- Manage assigned vigilance agreements with external business partners.
- Lead negotiations to define conditions and requirements of vigilance agreements.
- Maintain regular communication with internal and external stakeholders.
- Identify and resolve compliance and operational issues related to vigilance agreements.
- Ensure vigilance agreements are updated and maintained in the appropriate repository.
- Lead assigned transition projects within Pharmacovigilance and Patient Safety.
- Coordinate project teams and monitor project deliverables, milestones and timelines.
- Communicate regulatory and vigilance requirements to relevant internal functions and external partners.
- Support corrective actions related to compliance and reconciliation issues.
- Assist with training and communication regarding Novartis pharmacovigilance standards and procedures.
- Represent External Vigilance Engagements in internal and external meetings.
- Support internal audits, partner audits and regulatory inspections.
- Work collaboratively with cross-functional teams in a matrix environment.
Qualification
Candidates should have:
- A degree in Biomedical Science or a related scientific discipline.
- A higher degree is desirable.
- Strong knowledge of pharmacovigilance and/or device vigilance.
- Knowledge of clinical safety reporting requirements and safety databases.
Experience Required
- 2–5 years of experience in clinical safety, pharmacovigilance, regulatory compliance or a related field.
- Experience in clinical trial safety is preferred.
- Knowledge of clinical safety reporting requirements and safety databases.
- Understanding of current pharmaceutical industry regulations and guidelines.
- Experience with vigilance agreements, partner management or transition projects will be advantageous.
Required Skills
- Pharmacovigilance
- Clinical Safety
- Safety Science
- Regulatory Compliance
- Device Vigilance
- Vigilance Agreements
- Partner Management
- Negotiation
- Problem Solving
- Cross-functional Collaboration
- Employee Training
- Project Management
- Knowledge of industry regulations and guidelines
Job Responsibilities at a Glance
The role primarily focuses on external vigilance engagement, pharmacovigilance agreements, partner management, regulatory compliance and transition projects. The candidate will work with multiple stakeholders and support Novartis’ vigilance processes across different business arrangements.
How to Apply
Interested and eligible candidates can apply online through the official Novartis careers portal.
Company: Novartis
Position: External Vigilance Engagements Lead
Location: Hyderabad
Experience: 2–5 Years
Job ID: REQ-10088191
Last Date: October 9, 2026
Apply Online
Note: Candidates should verify the latest job details, eligibility requirements and application status on the official Novartis careers portal before applying.