Pharmacovigilance Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee and enhance drug safety operations in clinical trials.

• Manage contractual, procedural, and regulatory obligations for both local and global projects.

• Facilitate communication with functional teams regarding program and organizational matters.

• Work together on problem-solving initiatives and system enhancements.

• Review pharmacovigilance literature and information sources to remain updated on regulations, practices, procedures, and proposals.

• Maintain a fundamental medical understanding of relevant therapeutic areas and disease conditions.

• Participate in on-call responsibilities and ensure 24-hour case intake coverage as necessary.

• Provide project plans and reliable forecasts.

• Act as a resource for departmental leaders and spearhead departmental initiatives.

• Prepare and deliver proposals.

• Oversee experienced professional staff, including recruitment, development, performance management, coaching, counseling, and separations.

• Authorize salary administration, hiring decisions, corrective actions, terminations, time records, expense reports, leave requests, and overtime.

⛳️ Requirements

• Bachelor's degree or equivalent relevant formal academic/vocational qualification, alongside 3+ years of safety experience.

• Prior experience similar to at least 5 years.

• Minimum of 1 year in a leadership role.

• Solid understanding of global regulatory standards and procedural compliance.

• Strong knowledge of pertinent therapeutic areas for managing adverse events.

• General understanding of pathophysiology and disease mechanisms.

• Effective time management and project management abilities.

• Proficiency in Microsoft Office applications and safety databases.

• Good command of English with the capability to translate information into the local language when necessary.

• Exceptional oral and written communication skills.

• Strong attention to detail and precision.

• Excellent critical thinking, problem-solving, and decision-making abilities.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• A global team-oriented environment.

• A work setting focused on scientific excellence.