Global ICSR Team Lead — Pharmacovigilance

Ergomed; Lazio; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Ergomed Group's PrimeVigilance division is hiring a Team Leader for ICSR management to guide a skilled team and liaise with clients while ensuring high safety data quality. We value curiosity, problem-solvers, and a collaborative spirit as we support pharmacovigilance from development to post-marketing.

English fluency, strong communication, and leadership are essential for this role in a global environment.

Competenze

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance.
• Strong previous work experience in pharmacovigilance with minimum 1 year in line manager role.
• Medical Device experience required
• Excellent communication (written and verbal) skills
• Organization skills, including attention to details and multitasking
• Delegation skills
• Planning and time management
• Technical skills
• Team working
• English – fluent (spoken, written)
• Advanced literacy (MS Office)

Mansioni

• Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader and Line manages ICSR staff.
• Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process.
• Assures and exerts activities leading to effective cooperation with clients in the area of ICSR Management.
• Contributes to achieving company´s goals and objectives.
• Works under supervision of ICSR Operational Lead.
• Providing support to other activities undertaken by the project team on behalf of the client and the company.
• Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency).
• Proposes process changes to ICSR Operational Lead.
• Manages ICSR deviations with ICSR Operational Lead support.
• Reviews trackers and timesheet data and ensures accuracy.
• Is involved in ICSR processing and 2nd QC of cases.
• Support other departments, as approved and instructed by ICSR Operational Lead.
• Operates as the assigned team SME.
• Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager.

Conoscenze

Pharmacovigilance

Team leadership

English fluency

Communication skills

Organization skills

Multitasking

Planning

Delegation

Technical skills

MS Office

Team collaboration

Formazione

Life science degree

Strumenti

MS Office

Descrizione del lavoro

Ergomed Group's PrimeVigilance division is hiring a Team Leader for ICSR management to guide a skilled team and liaise with clients while ensuring high safety data quality. We value curiosity, problem-solvers, and a collaborative spirit as we support pharmacovigilance from development to post-marketing.

English fluency, strong communication, and leadership are essential for this role in a global environment.