Pharmacovigilance Safety Manager

This is a fully remote position, open to applicants in United States, +2 more countries.

📋 Description

• Manage the PV Safety Management process for clinical trials, ensuring the delivery of safety activities is both high-quality and compliant.

• Direct and support the Safety Team, offering daily leadership, guidance, and oversight of assigned tasks.

• Act as the main safety liaison for sponsors, clinical project managers, the QPS Safety Team, and other stakeholders involved.

• Provide expertise on global safety reporting requirements and ensure adherence to relevant regulations and guidelines, including GCP and EudraVigilance standards.

• Create and maintain Clinical Safety Management Plans, safety databases, procedures, and associated documentation.

• Lead clinical safety meetings and foster effective communication among sponsors, project teams, subcontractors, and other key parties.

• Collaborate with Finance and project teams on project initiation, budgeting, and invoicing for PV services.

⛳️ Requirements

• In-depth knowledge of international clinical safety reporting regulations and guidelines, including GCP and EudraVigilance.

• Ability to act as a key resource for global safety guidance.

• Practical understanding of safety reporting requirements in clinical studies.

• Proven track record in clinical trials, a CRO environment, or a related field.

• Experience in leading, supervising, or providing daily direction to PV/safety team members.

• Outstanding organizational and communication abilities.

• Proficient in business-level English.

• Strong analytical skills, with the capability to research, assess, and apply complex information effectively.

• Keen attention to standards, quality, and impact, demonstrating thoroughness and accuracy.

• Bachelor's degree in a relevant discipline or an equivalent combination of education and experience.

🏝️ Benefits

• Opportunities for personal and professional growth.

• Support from seasoned professionals for ongoing development and career aspirations.

• Established Career Ladders.

• Performance-driven rewards, including bonuses and merit increases tied to individual, team, and company achievements.

• Company-matched 401(k) plan.

• Company-sponsored Group Life/AD&D insurance.

• Short- and Long-term Disability Insurance.

• Employee-focused internal committees designed to cater to the needs, interests, and enjoyment of QPS employees.

• A welcoming environment where performance is acknowledged and rewarded.

• Training and opportunities for advancement.