Senior Safety Specialist - Pharmacovigilance

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
 

At Gilead Sciences, we’re driven by our mission to discover, develop, and deliver innovative therapeutics for patients with life-threatening diseases. As part of our ongoing commitment to patient safety and regulatory excellence, we are seeking an experienced Senior Safety Specialist to support our South Korea Affiliate’s pharmacovigilance (PV) operations. This critical role offers the opportunity to make a meaningful impact on public health while working in an inclusive and collaborative environment.

🚀 About the Role:

The Senior Safety Specialist serves as a key member of our local Patient Safety (PS) team, supporting the Affiliate Head of Patient Safety and global safety functions. You will have the opportunity support and/or manage critical PV activities, serve as a local safety expert, ensure regulatory compliance, and contribute to strategic initiatives that align with both local and global safety objectives.

🧩 Key Responsibilities Include:

1. Strategic Pharmacovigilance Leadership

• Act as a strategic PV partner, providing local insights into global risk-benefit assessments.
• Collaborate with global safety teams and local stakeholders to ensure safe and compliant product launches and life-cycle management.
• Contribute expert input into local post-marketing surveillance (PMS) studies, investigator-initiated research (IIR), and solicited safety programs.

2. Regulatory Compliance and Inspection Readiness

• Serve as the local contact for pharmacovigilance audits and regulatory inspections.
• Ensure accurate and timely submissions to Health Authorities (e.g., PSURs, RMPs, signal assessments).
• Maintain an up-to-date understanding of local PV regulations, translating these into operational requirements and contributing to regulatory consultations.

3. Operational Oversight

• Lead local risk management planning, including development of country-specific annexes and risk minimization measures.
• Provide safety oversight of digital media campaigns, patient support programs, and market research initiatives to ensure compliance and mitigate risks.
• Monitor the safety profiles of marketed products and escalate safety concerns as necessary.

4. Training, Quality, and Process Excellence

• Develop and deliver engaging internal training on pharmacovigilance requirements and practices.
• Maintain the local Quality Management System (QMS), including SOPs, safety procedures, deviations, and corrective actions.
• Ensure business continuity and oversight of safety-related systems and reporting tools.

5. Cross-functional Collaboration

• Actively participate in industry forums and affiliate leadership meetings, representing the PS function and contributing best practices.
• Support contract review processes and ensure alignment with global PV standards for local partnerships.
• Liaise with global and regional colleagues to harmonize PV standards, data privacy requirements, and data retention practices.

✅ Minimum Requirements:

• Experience: Minimum of 4 years in the pharmaceutical industry, including hands-on pharmacovigilance experience within affiliate operations.
• Communication: Demonstrates ethical, clear, and adaptive communication with internal teams, regulators, and external partners.
• Teamwork & Independence: Works well both independently and as part of diverse, cross-functional teams; embraces cultural diversity and team collaboration.
• Languages: Fluency in Korean and English (spoken and written) is required.

💼 What Gilead Offers:

• A purpose-driven and inclusive work environment.
• Career development through continuous learning and leadership opportunities.
• Competitive salary and comprehensive benefits.
• The opportunity to be part of a company that is making a tangible difference in the world.

Please apply via the Internal Career Opportunities portal in Workday.