SERM Safety & Pharmacovigilance Director

GSK; Durham (NC); On-site; USD 170,000 - 283,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Paid holidays

Job summary

GSK is seeking a Senior Scientist in Pharmacovigilance to lead safety governance, risk management planning, and global regulatory submissions. You will guide cross-functional teams in clinical development and post-marketing efforts to ensure safe, compliant data-driven decisions.

Requires a PhD or PharmD with 5+ years in pharma/biotech pharmacovigilance, expertise in signal detection and regulatory standards; strong leadership in matrix settings and clear regulatory communication.

Qualifications

• Pharmacovigilance experience in pharma/biotech
• Experience with safety evaluation and risk management
• Knowledge of international pharmacovigilance requirements (ICH, GVP)
• Experience leading cross-functional/ matrix teams
• Strong communication and leadership skills

Responsibilities

• Lead safety governance and safety strategy development for products in clinical development and post-marketing settings.
• Coordinate cross-functional teams to identify and manage safety issues and ensure risk-reduction actions.
• Represent safety perspectives in regulatory discussions and internal governance meetings.
• Drive process improvements to meet regulatory standards and data quality requirements.

Skills

Pharmacovigilance

Safety Evaluation

Risk Management

Regulatory Submissions

Signal Detection

GVP familiarity

Matrix Organization Leadership

Education

PhD in Life Sciences/Pharmacology/Related

Bachelor's degree in Life Sciences

Job description

GSK is seeking a Senior Scientist in Pharmacovigilance to lead safety governance, risk management planning, and global regulatory submissions. You will guide cross-functional teams in clinical development and post-marketing efforts to ensure safe, compliant data-driven decisions.

Requires a PhD or PharmD with 5+ years in pharma/biotech pharmacovigilance, expertise in signal detection and regulatory standards; strong leadership in matrix settings and clear regulatory communication.