Medical Safety Lead (Pharmaceutical, EMEA)

Job summary

The Medical Safety Lead is responsible for overseeing the assessment of medical safety data for assigned products, developing safety signaling and benefit-risk management strategies, and collaborating with various stakeholders to ensure the safe use of products.

Qualifications

• MD required; active medical license preferred.
• Minimum of 2 years of clinical experience with direct responsibility for diagnostic and treatment decisions.
• At least 5 years of experience in medical review and assessment of safety information/Pharmacovigilance.

Responsibilities

• Provide strategic leadership in medical safety for assigned products.
• Conduct safety signal management and benefit-risk assessments.
• Lead cross-functional teams in reviewing aggregate safety data.
• Develop safety governance structures and contribute to regulatory submission documents.
• Prepare and review safety sections of clinical and regulatory documents.
• Respond to regulatory authority inquiries regarding safety information.
• Prepare periodic safety reports and oversee individual case safety reports.
• Lead presentations of safety information to Data Safety Monitoring Boards.
• Support the development of Standard Operating Procedures and training on adverse event reporting.

Skills

• Strong scientific and analytical skills.
• Ability to manage multiple tasks in a fast-paced environment.
• Excellent leadership and collaboration skills with multidisciplinary teams.
• Strong presentation and communication skills.

Education

• MD required; active medical license preferred.

Tools

• Knowledge of pharmacovigilance regulatory requirements and adverse event reporting systems.