Global Medical Safety Leader

EMD Serono, Inc.; Billerica (MA); On-site; USD 208,000 - 312,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

EMD Serono, Inc. in the United States seeks a GPS Global Safety Lead to steer integrated safety strategies across development programs and marketed products.

You will provide scientific leadership, oversee safety surveillance, signal detection, and risk management, and collaborate with regulatory bodies and cross-functional teams to ensure compliant safety reporting throughout the product lifecycle. The role requires a medical or pharmacy degree with 5+ years in drug

Qualifications

• MD or DO/PharmD with 5+ years in drug development or pharmacovigilance.
• Expert understanding of regulatory requirements and safety reporting.
• Experience authoring safety submissions and interacting with authorities.

Responsibilities

• Lead safety strategies across development programs and marketed products.
• Oversee proactive safety surveillance, signal detection and risk management.
• Engage with regulatory authorities and contribute to regulatory submissions and governance.

Skills

Medical degree

Pharmacovigilance experience

Regulatory submissions

Safety signal management

Data analytics

Oncology knowledge

Cross-functional leadership

Education

MD or PharmD

Tools

Regulatory submissions processes

Job description

EMD Serono, Inc. in the United States seeks a GPS Global Safety Lead to steer integrated safety strategies across development programs and marketed products.

You will provide scientific leadership, oversee safety surveillance, signal detection, and risk management, and collaborate with regulatory bodies and cross-functional teams to ensure compliant safety reporting throughout the product lifecycle. The role requires a medical or pharmacy degree with 5+ years in drug