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

Medicine moves forward here. So will you. 

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-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from. 

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

Job Description

• 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 of ICSR Operational Lead
• ​​Role and Responsibilities​ 
• 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 

Qualifications

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

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join 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 the outcome, because someone is waiting on it. 

• Agility and responsiveness: we move quickly, because patients cannot wait. 

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

• Collaborative partnerships: we go further by going together. 

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