Senior Pharmacovigilance Officer, Team Lead – Medical Device Experience

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

📋 Description

• Leads a team focused on ICSR management for designated projects or groups of projects as the Team Leader and manages ICSR staff.

• Ensures effective distribution of tasks among assigned projects and teams while overseeing the workflow process.

• Guarantees productive collaboration with clients in the domain of ICSR Management.

• Contributes to the accomplishment of the company’s objectives and goals.

• Works under the guidance of the ICSR Operational Lead.

• Provides assistance to other activities carried out by the project team on behalf of both the client and the company.

• Develops and maintains project-specific KPIs for contracted ICSR activities, which includes optimizing procedures, training, and other initiatives to enhance ICSR team efficiency.

• Suggests process modifications to the ICSR Operational Lead.

• Manages deviations in ICSR with the support of the ICSR Operational Lead.

• Reviews trackers and timesheet information to ensure correctness.

• Participates in ICSR processing and second quality control of cases.

• Supports other departments as directed and approved by the ICSR Operational Lead.

• Acts as the Subject Matter Expert (SME) for the assigned team.

• Provides support to the RA & PV Network Department as needed, including serving as the Local Contact Person for Pharmacovigilance (LCPPV) for the specified country and taking on the role of Person Responsible for Local Screening (PRLS) for the designated language, as agreed with the line manager.

⛳️ Requirements

• Degree in life sciences, pharmacy, nursing, or other healthcare-related qualifications, or relevant experience in pharmacovigilance.

• Significant prior experience in pharmacovigilance, including a minimum of one year in a line management role.

• Experience with medical devices is required.

• Exceptional verbal and written communication skills.

• Strong organizational abilities, with a keen attention to detail and the capability to handle multiple tasks simultaneously.

• Proficient delegation skills.

• Effective planning and time management skills.

• Technical proficiency.

• Ability to work collaboratively within a team.

• Fluent in English (both spoken and written).

• Advanced proficiency in MS Office.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• Strong focus on personal and professional development.

• A friendly and supportive working environment.

• Chance to collaborate with colleagues from around the globe, with English as the primary company language.