Associate Director, Program Safety Lead (Biopharmaceutical, Hellerup)

Job summary

This role involves leading safety strategies and document development within a global biopharmaceutical context, focusing on patient safety and signal evaluation.

Qualifications

• Doctoral or master’s degree in medicine or pharmacy.
• At least 8 years of experience in patient safety.
• Proven experience in safety data analysis, signal evaluation, and medical writing.
• Strong knowledge of FDA and EMA pharmacovigilance regulations and ICH Guidelines.

Responsibilities

• Develop and implement safety strategies for assigned products in collaboration with Program Safety Leads and stakeholders.
• Support day-to-day tasks for PSLs, including data review and preparation of safety-related deliverables.
• Collaborate with Medical Assessment and Signal Detection Leads for consistent oversight of safety data.
• Provide strategic input for safety sections of key documents ensuring clarity and medical accuracy.
• Conduct regular surveillance of safety data and assess potential safety issues.
• Contribute to signal detection, evaluation, and documentation per SOPs and regulatory expectations.
• Draft and review safety-related documents such as expedited reports and clinical study reports.
• Ensure accuracy and inspection-readiness of all safety documentation.
• Support Drug Safety Committee meetings with agenda planning and documentation.

Skills

• Strong analytical and organizational skills.
• Excellent communication abilities.
• Team player with a proactive attitude and entrepreneurial mindset.

Education

• Doctoral or master’s degree in medicine or pharmacy.

Tools

• Familiarity with pharmacovigilance software and safety data analysis tools is beneficial.