Title:
Safety Data Exchange Agreements (SDEA) Specialist
Location:
Remote
Schedule:
Standard EST Hours
Duration:
12-Month Contract
Pay Range:$65.00 - $75.00/hr
Safety Data Exchange Agreements (SDEA) Specialist
This role partners with cross-functional internal teams and external global stakeholders to support the execution, compliance, and management of Safety Data Exchange Agreements (SDEAs). The position requires strong collaboration, process management, and attention to regulatory and contractual requirements.
What You’ll Do
Stakeholder Collaboration & SDEA Execution
- Partner with internal and external stakeholders to assess the need for SDEAs and support their execution and ongoing compliance.
- Review corporate agreements to determine applicability and alignment with safety data exchange requirements.
- Draft, revise, and execute SDEAs in collaboration with subject matter experts (SMEs) and external partners, ensuring timely completion.
- Identify and confirm responsible parties for SDEA commitments.
- Support SMEs with stakeholder or partner inquiries related to SDEAs.
- Assist with audit and inspection preparation, as well as response activities related to SDEAs.
Process Management & Improvement
- Manage and enhance processes supporting SDEA execution, compliance, and transparency.
- Track commitments and ensure inspection readiness.
- Identify, implement, and manage process improvements to increase efficiency and effectiveness across SDEA-related activities.
Required Skills & Qualifications
Experience & Knowledge
- Experience with safety agreements or safety-related contracts.
- Alliance or partnership management experience.
- Minimum of 5 years of experience in pharmacovigilance.
- Bachelor’s degree in related field.
Core Competencies
- Strong analytical, written, and verbal communication skills.
- Ability to listen, negotiate, assess impact, prioritize, and deliver compliant solutions.
- Project management experience with the ability to manage competing priorities.
- High level of attention to detail and organizational skills.
- Flexibility and adaptability in a fast-paced, cross-functional environment.
- Comfort working with broad stakeholder networks and resolving complex challenges.
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