Pharmacovigilance Officer with Medical Device Experience

Company Overview

PrimeVigilance is dedicated to advancing medicine by prioritizing patient safety at every stage, from early drug development through post-marketing surveillance. As a global pharmacovigilance specialist, the company helps clients comply with complex regulations while emphasizing meaningful interpretation of safety data to generate actionable insights. The workplace culture promotes kindness, flexibility, personal growth, and inclusion across its global teams.

Role Summary and Responsibilities

• Assist project teams with various activities serving clients and the organization.
• Develop and maintain project-specific key performance indicators (KPIs) for Individual Case Safety Report (ICSR) activities, including optimizing related procedures and trainings to enhance team efficiency.
• Recommend process improvements to the ICSR Operational Lead.
• Manage ICSR deviations with support from the ICSR Operational Lead.
• Review trackers and timesheet data to ensure accuracy.
• Perform ICSR processing and conduct second-level quality control of cases.
• Provide support to other company departments as needed.
• Serve as the assigned Subject Matter Expert (SME) for the team.
• Support Regulatory Affairs and Pharmacovigilance Network Departments, including acting as the Local Contact Person for Pharmacovigilance (LCPPV) and the Person Responsible for Local Screening (PRLS) in the designated language and country, as directed by management.

Qualifications and Skills

• Degree in Life Sciences, Pharmacy, Nursing, or a healthcare-related field, or equivalent pharmacovigilance experience.
• 3-4 years of pharmacovigilance experience, including at least 1 year in a line management role.
• Excellent verbal and written communication abilities.
• Strong organizational skills, with an emphasis on attention to detail and multitasking capabilities.
• Delegation and leadership skills.
• Effective planning and time management.
• Proficient technical skills relevant to the role.
• Ability to work collaboratively within a team.
• Fluency in English, both spoken and written.

Additional Information

By joining PrimeVigilance, part of the Ergomed Group, you contribute to delivering safe and effective pharmaceutical treatments worldwide. The company values quality, integrity, passion, agility, inclusiveness, and collaborative teamwork. These core principles guide all work and contribute to a supportive and dynamic environment.