Senior Specialist, Client Facing Scientific Consulting

This is a fully remote position, open to applicants in Spain, +1 more country.

📋 Description

• Prepare and manage documents related to projects.

• Compile PSMFs, serve as the PSMF Coordinator, and guarantee review/approval by the QPPV along with prompt submission to authorities as required.

• Conduct quality checks on PSMFs before they receive QPPV approval.

• Engage in pharmacovigilance projects for clients, leveraging your experience and qualifications.

• Negotiate, update, and dissolve PVAs, encompassing SDEAs, PV Service Agreements, and Quality Technical Agreements.

• Execute administrative duties that support the QPPV and the PER PV GOV Practice Area.

• Lead small projects such as QPPV/PSMF or PVA services as the Project Lead.

• Assume primary tasks and responsibilities across different service lines, manage project activities as the client contact point, and undertake additional reasonable tasks in line with your skills, qualifications, and training.

⛳️ Requirements

• A university degree in Life Sciences is preferred but not mandatory.

• Required experience in pharmacovigilance, drug safety, epidemiology, risk management, scientific consulting, regulatory affairs, or a comparable field.

• Certification in pharmacovigilance or drug safety is preferred.

• Certification in regulatory affairs or clinical safety is preferred.

• Certification in quality management or auditing is preferred.

• Capability to perform responsibilities that align with your skills, qualifications, and training.

🏝️ Benefits

• Benefit offerings outside the US may vary by country and will be aligned with local market practices.

• Equal employment opportunity.

• Reasonable accommodations during the employment process for individuals with disabilities.