Head Medical Safety Assessment and External Engagement

Novartis India; Hyderabad; On-site; INR 600,000 - 800,000; Full time

Job summary

Novartis India seeks a Senior Medical Safety Leader to guide strategic planning for Medical Safety Experts within Safety Operations. Lead outsourcing decisions, coordinate audits, and build a high-performing team while aligning with global safety standards.

You will liaise with heads of development units to drive training and ensure compliant, timely delivery of safety activities across Therapeutic Areas.

Qualifications

• 10+ years experience in drug development including safety/pharmacovigilance.
• At least 3 years leading medical teams in matrix environments.
• Excellent negotiation and influencing skills.
• Ability to mentor associates and coordinate interactions with internal and external partners.
• Proven leadership in creating and developing global safety/pharmacovigilance teams and leading strategic growth.
• Ability to work independently under pressure, meet tight deadlines, demonstrate high initiative and flexibility.
• Demonstrated effective and innovative leadership.
• Excellent organizational, planning, resource, and global project management skills.
• Superior people‑management skills with positive, innovative, collaborative behaviors.
• Clinical research and clinical trials expertise.
• Cross‑functional teamwork.
• Leadership.
• Process safety management.
• Regulatory compliance.
• Risk management.
• Safety science.
• Strategy development

Responsibilities

• Manage strategic planning of activities delivered by Medical Safety Experts within Medical Safety Operations.
• Make outsourcing decisions and assessments for Medical Safety.
• Manage audit/inspection requests pertaining to medical review of individual cases.
• Build a high‑performing team; recruit, retain and develop talent; assess resource needs regularly to achieve operational efficiency and support process excellence.
• Liaise with Head Patient Safety of all Development Units to obtain feedback on performance of Medical Safety Experts and ensure appropriate training is provided.
• Organize and plan deliverables of Medical Safety Experts according to pre‑planned schedule and ad‑hoc requests from Therapeutic Areas, ensuring compliance with patient safety business rules.
• Ensure preparation and training of Medical Safety Experts is of high standard to deliver activities with quality, timeliness, and compliance.

Skills

Strategic leadership

People management

Stakeholder management

Mentoring & coaching

Negotiation

Matrix leadership

Regulatory compliance

Risk management

Clinical research

Cross-functional teamwork

Job description

ROLE

• Manage strategic planning of activities delivered by Medical Safety Experts within Medical Safety Operations.
• Make outsourcing decisions and assessments for Medical Safety.
• Manage audit/inspection requests pertaining to medical review of individual cases.
• Build a high‑performing team; recruit, retain and develop talent; assess resource needs regularly to achieve operational efficiency and support process excellence.
• Liaise with Head Patient Safety of all Development Units to obtain feedback on performance of Medical Safety Experts and ensure appropriate training is provided.
• Organize and plan deliverables of Medical Safety Experts according to pre‑planned schedule and ad‑hoc requests from Therapeutic Areas, ensuring compliance with patient safety business rules.
• Ensure preparation and training of Medical Safety Experts is of high standard to deliver activities with quality, timeliness, and compliance.

REQUIREMENTS

• Minimum 10 years experience in drug development, including safety/pharmacovigilance.
• At least 3 years experience managing medical teams and matrix environments.
• Excellent negotiation and influencing skills.
• Ability to mentor and coach associates and coordinate interactions with internal and external partners.
• Proven leadership in creating and developing global safety/pharmacovigilance teams and leading strategic growth.
• Ability to work independently under pressure, meet tight deadlines, demonstrate high initiative and flexibility.
• Demonstrated effective and innovative leadership.
• Excellent organizational, planning, resource, and global project management skills.
• Superior people‑management skills with positive, innovative, collaborative behaviors.
• Clinical research and clinical trials expertise.
• Cross‑functional teamwork.
• Leadership.
• Process safety management.
• Regulatory compliance.
• Risk management.
• Safety science.
• Strategy development