Manager, PV – Medical Project Coordinator Team

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

📋 Description

• Oversee various elements of projects, both locally and internationally, including contractual, procedural, and regulatory requirements.

• Foster effective communication with other functional teams regarding program and company matters.

• Collaborate with colleagues to solve problems and enhance systems.

• Analyze regulatory and pharmacovigilance publications and information sources to stay informed about current regulations, practices, procedures, and proposals.

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

• May engage in on-call responsibilities for specific projects and ensure 24-hour coverage for case intake from investigative sites.

• Develop plans and provide precise forecasts for all projects.

• Act as a resource for other department managers and lead departmental initiatives.

• Prepare and deliver proposals.

• Supervise a team of experienced professionals, which may involve interviewing and selection, preparing job descriptions, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approve decisions related to salary administration, hiring, corrective actions, and terminations.

• Review and authorize time records, expense reports, leave requests, and overtime.

⛳️ Requirements

• Bachelor's degree or equivalent relevant formal academic/vocational qualification with at least 3 years of safety experience.

• Prior experience that provides the knowledge, skills, and abilities necessary to perform the role (equivalent to 5+ years).

• At least 1 year of leadership experience.

• Familiarity with global regulatory requirements and the significance of compliance with procedural documents.

• Strong understanding of pertinent therapeutic areas necessary for processing adverse events (AEs).

• General knowledge of pathophysiology and disease processes.

• Effective time management and project management skills.

• Proficient in Microsoft Office products and safety databases.

• Good command of English with the ability to translate information into the local language as needed.

• Exceptional oral and written communication skills.

• Strong attention to detail and accuracy.

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

🏝️ Benefits

• Flexible work arrangements.

• Professional development opportunities.