External Vigilance Engagements Lead

IN10 (FCRS = IN010) Novartis Healthcare Private Limited; Hyderabad; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Novartis Healthcare Private Limited seeks an experienced pharmacovigilance professional to provide expertise on PV and device vigilance across Enterprise contractual arrangements, including global/local vigilance agreements and transition projects. You will manage negotiations, alliances, and ensure regulatory compliance while coordinating with Development, PS&PV, and external customers.

The role requires knowledge of PV regulations, risk assessment, and strong stakeholder communication across

Qualifications

• Degree in Biomedical Science or related scientific discipline.
• Higher degree desirable.

Responsibilities

• Maintain knowledge of regulations/guidelines for pharmacovigilance and device vigilance and advise Novartis line-units and external partners.
• Lead negotiations to define conditions of vigilance agreements with external partners.
• Manage vigilance agreements and ensure compliance and timely updates in the repository.
• Lead transition projects in PS&PV and coordinate cross-functional teams.

Skills

Pharmacovigilance

Regulatory compliance

Negotiation

Cross-functional collaboration

Safety reporting

Education

Biomedical Science degree

Higher degree desirable

Tools

Pharmacovigilance database

Job description

Job Description Summary

Provide expertise and cross functional leadership on pharmacovigilance and/or device vigilance for all assigned Novartis Enterprise contractual arrangements including Global and Local Vigilance Agreements, and Clinical Trial Supply Agreements; and the management of transition of vigilance systems and processes (including for medical devices, and diagnostic portfolios) as part of Mer-gers & Acquisitions, divestments, in and out-licensing and other global strategic projects. Negoti-ate and maintain vigilance agreements with external business partners, managing these alliances, including oversight of compliance, and acting as key contact person for Development, PS&PV and external customers.

Job Description Major Accountabilities

Expertise - Maintain knowledge of current and developing regulations/guidelines for pharmacovigilance and/or device vigilance and provide expertise and advice to all concerned Novartis line-units and external partners for Novartis Enterprise contractual arrangements and Development Integration teams (Transitions), if applicable. Strategy/VAP Risk Assessment (VAPRA) – take part in VAPRA activities for new deals as required to assess potential partner’s PV systems for the impact on the Novartis Enterprise. Negotiation and Alliance Management– Manage assigned vigilance agreements with external business partners by leading negotiations to define conditions of the agreement, guided by the EVE Director/EVE Associate Director. Ensure regular contact with key customers to facilitate agreement compliance and good relations and acting as key contact person for external and internal stakeholders to identify needs and address resolution of issues. Initiate appropriate updates to vigilance agreements in a timely manner; support Head EVE / EVE Director to ensure that vigilance agreements are implemented as required to maintain regulatory compliance and Development PS&PV standards. Ensure accuracy and up-to-date information of agreements in the vigilance agreement repository. Lead assigned transition projects in PS&PV, which are of high priority/criticality to the business, by implementing the strategy defined in alignment with the Development Integration strategy and assembling the appropriate teams and supervising/directing their work. Escalate to the line function managers as appropriate any potential disruption of the project plan in a timely manner to avoid delays/failures in transition project deliverables. Maintain the project team's awareness of strategic changes in project goals, status, and milestones at all times, as communicated by the Head EVE/ EVE Director. Regulatory and Partner Compliance – communicate requirements to PS&PV functions and external line-units to ensure compliance with vigilance agreements and with transition project plan as required; with Head EVE / EVE Director and Compliance Team, ensure external business partners and PS&PV management are alerted to compliance and reconciliation issues and have oversight of corrective actions and their effectiveness to improve and maintain a high level of compliance. Training and communication – Assist in the development, maintenance and training Novartis PS&PV and other concerned departments on worldwide Novartis pharmacovigilance standards & procedures for pharmacovigilance agreements, using internal guidelines, tools and templates. Represent External Vigilance Engagements in internal and external meetings as needed, guided by EVE Director/EVE Associate Director as required. Audits and Inspections: support internal Novartis and VAP audits, Novartis audits of VAPs, VAP regulatory inspections, Novartis regulatory inspections, including those covering transition projects .

Essential Requirement

Degree in Biomedical Science or related scientific discipline. Higher degree desirable. Minimum 2 – 5 years’ experience in clinical safety/ (pharmaco)vigilance or in a regulatory/compliance related area including a thorough knowledge of the functional requirements of clinical safety reporting and a clinical safety database. Good current knowledge of industry regulations and guidelines in the field of Pharmacovigilance and/or device vigilance. Experience in Clinical Trial Safety preferable. Candidates should have knowledge of clinical safety-reporting requirements, safety databases and relevant industry regulations. Clinical trial safety experience is preferred, while experience with vigilance agreements, partner management or transition projects would be advantageous. Strong interpersonal communication skills and negotiation/problem solving skills Experience and ability to work in matrix cross-functional environments.

Skills Desired

Employee Training, Pharmacovigilance, Safety Science, Waterfall Model Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

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