Drug Safety Complaince Consultant

Description:

• Remote opportunity EST hours.
• 40 Hours per week.
• Full time Contract Role.

About This Role:

This position will work with cross-functional internal and external global stakeholders of all levels to execute safety data exchange agreements (SDEAs).

What You ll Do:

Outreach and collaboration with different stakeholders to assess the need and support the execution and compliance of SDEAs. Tasks include, but are not limited to:

• Corporate agreement review.
• Author, revise and execute on time SDEAs with SMEs and corporate partners.
• Identify and collaborate to confirm SDEA commitments responsible parties.
• Support subject matter expert in SDEA stakeholder or partner inquiries, audit and inspection prep and responses.
• Manage and enhance processes for SDEA execution, compliance and transparency.
• Identify, manage and implement process enhancements to improve the efficiency and effectiveness of how we work (on areas such as: SDEA executions, compliance and inspection readiness and/or commitment tracking).

Required Skills:

• Safety agreement or safety contracts experience.
• Excellent analytical and communication skills.
• Ability to listen, negotiate, assess impact, prioritize, and successfully communicate and deliver compliant verbal and written solutions.
• Project Management.
• Flexibility and being able to manage competing priorities.
• Excellent attention to detail.
• Alliance management experience.
• Enjoy multi-tasking, process management, wide networks, solving challenges, and engaging others for optimal outcomes.
• Microsoft Word proficiency (template creation and maintenance, doc. mgmt. tools).
• S. in life sciences and ? 5 years of experience in pharmacovigilance.