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Medical Safety Lead - Job Opportunity at Sandoz (Novartis)

Holzkirchen, Germany
Full-time
Senior
Posted: January 16, 2025
On-site
EUR 85,000 - 115,000 annually based on location and seniority

Benefits

30 days annual leave with above-market vacation allowance
Comprehensive company pension scheme with capital formation benefits
Enhanced parental leave program exceeding statutory requirements
Sustainable mobility program including company bike leasing
Premium learning and development platform access (Coursera with 200,000+ videos)
Special occasion rewards and recognition program
Competitive healthcare and insurance package

Key Responsibilities

Lead global pharmacovigilance strategy and safety profile management for assigned products
Direct risk management and periodic safety reporting processes
Conduct high-level medical assessments of product quality and safety signals
Manage regulatory authority interactions and safety-related inquiries
Drive safety document preparation and review for regulatory submissions
Lead cross-functional safety initiatives and collaborations
Oversee post-marketing surveillance and medical device safety compliance

Requirements

Education

Medical Degree (MBBS/MD) preferred, or BSc Pharmacy/Nursing/PharmD/PhD in relevant field

Experience

Minimum 4 years in pharmaceutical industry with 2 years in patient safety

Required Skills

Safety signal detection and evaluation Risk management planning Regulatory report preparation Clinical safety assessment Medical writing Cross-functional collaboration Issue management Decision making on safety topics Fluent English proficiency
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on real-world evidence and post-marketing safety surveillance in pharmaceutical industry Growing importance of biosimilars in global healthcare markets Rising regulatory scrutiny and compliance requirements in pharmacovigilance Shift towards integrated safety assessment approaches combining traditional and novel data sources

Role Significance

Typically leads or coordinates with 5-10 direct reports and extensive matrix management
Senior leadership position with significant influence on global safety strategy and risk management

Key Projects

Global safety profile management for multiple products Regulatory authority interactions and submissions Cross-functional safety initiatives Post-marketing surveillance programs

Success Factors

Deep understanding of global pharmacovigilance requirements Strong medical and scientific background Excellence in stakeholder management and communication Strategic thinking and risk assessment capabilities Ability to influence without direct authority

Market Demand

High demand with growing emphasis on safety expertise in biosimilar development and post-marketing surveillance

Important Skills

Critical Skills

Medical expertise in safety assessment Regulatory strategy and compliance Risk management and signal detection Stakeholder management

Beneficial Skills

Digital health technologies Real-world evidence analysis Change management Business development acumen

Unique Aspects

Opportunity to shape safety strategy during company transformation
Focus on biosimilar development bringing unique challenges
Strong emphasis on sustainable healthcare access

Career Growth

2-4 years in role before advancement, depending on performance and organizational growth

Potential Next Roles

Global Head of Drug Safety Chief Safety Officer Senior Director of Pharmacovigilance Head of Medical Affairs

Company Overview

Sandoz (Novartis)

Sandoz is undergoing transformation as an independent entity, focusing on generic and biosimilar medicines leadership

Global leader in generics and biosimilars with strong market presence and growth potential
Strategic location in German pharmaceutical hub with global reach
Dynamic, transformation-oriented environment with focus on innovation and agility
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