Drug Safety Consultant I

Job Description

Job Summary:

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

Duties and Responsibilities:

• 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).

Education and Experience:

• B.S. in life sciences and- 5 years of experience in pharmacovigilance.
• Safety agreement or safety contracts experience.

Knowledge, Skills & Abilities:

• 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.
• End Product multi-tasking, process management, wide networks, solving challenges, and engaging others for optimal outcomes.
• Microsoft Word proficiency (template creation and maintenance, doc. mgmt. tools).