Senior Pharmacovigilance Officer, Team Lead/ Case Processing Manager- Medical Device experience needed

Ergomed; Leinster; On-site; EUR 70,000 - 95,000; Full time

Job summary

Ergomed's PrimeVigilance division seeks an experienced Team Leader to oversee ICSR management for assigned projects. You will line manage ICSR staff, distribute tasks, and drive efficient workflow while ensuring high standards in safety reporting.

You will collaborate with clients and internal RA & PV teams, maintain project KPIs, and support continuous improvements. English fluency, strong communication, and pharmacovigilance experience are essential.

Qualifications

• Life science graduate or healthcare qualification with pharmacovigilance experience.
• Minimum 1 year in a line manager role within pharmacovigilance.
• Medical Device experience required.
• Excellent communication (written and verbal) skills.
• Strong organizational and multitasking abilities.

Responsibilities

• 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 oversees the workflow process.
• Assures and exerts activities leading to effective cooperation with clients in ICSR Management.
• Creates and maintains project KPIs for contracted ICSR activities and drives process improvements.
• Proposes process changes to the ICSR Operational Lead and supports QA activities.
• Operates as the assigned team SME and supports RA & PV Network Department as needed.

Skills

Communication

Organization

Delegation

Planning & time management

Team working

English fluent

MS Office proficiency

Technical skills

Education

Life science/Pharmacy/Nursing or health qualification with pharmacovigilance experience

Job description

Medicine moves forward here. So willyou.

At PrimeVigilance, patient safety is not one part of the job. It is why we exist.

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.

That work takes curious minds, problem-solversand experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America,Asiaand Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another andgood ideasare heard wherever they come from.

If you want a role with real purpose, globalreachand the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.

• 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 of activities leading to effective cooperation with clients in the area of ICSR Management
• Contributes to achieving company´s goals and objectives
• Works under supervision ofICSR Operational Lead
• Role and Responsibilities
• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Createsand maintainsproject specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency)
• Proposes process changestoICSR OperationalLead
• ManagesICSR deviations withICSR Operational Leadsupport
• Reviewstrackers andtimesheet dataand ensuresaccuracy
• Is involved inICSR processingand2nd QC of cases
• Support other departments, as approved and instructed by ICSR Operational Lead
• Operates as the assigned teamSME
• 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

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
• Strong previouswork experience in pharmacovigilance within which minimum 1 year of work experience in line managerrole.
• 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)

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.You’lljoin a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality:we hold ourselves to the standard patients deserve.

• Integrity and trust:we do the right thing, especially when it is hard.

• Drive and passion:we care about theoutcome, becausesomeone is waitingonit.

• Agility and responsiveness:we movequickly, becausepatients cannot wait.

• Belonging:everyone is welcome, and every voice counts.

• Collaborative partnerships:we go further by going together.

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