Director, Pharmacovigilance

Pharmacovigilance Leadership:

• Lead global pharmacovigilance operations, including case management and vendor oversight.
• Provide medical and technical support for clinical projects, ensuring accurate evaluation of adverse events.
• Oversee safety submissions to global health authorities and collaborate with cross-functional teams.

Regulatory Compliance and Safety Management:

• Drive inspection readiness and respond to health authority inquiries.
• Maintain SOPs, safety management plans, and partner agreements for regulatory compliance.
• Expertise in safety databases, coding dictionaries, and safety data analysis.

Team Collaboration and Communication:

• Organize and lead Safety Management Team meetings to assess emerging safety concerns.
• Proven stakeholder management skills with experience guiding cross-functional teams.
• Exceptional communication skills for presenting complex safety data to diverse audiences.