Junior PV Officer

SmartRecruiters, Inc.; Lisboa; Híbrido; EUR 40 000 - 56 000; Tempo integral

Resumo da oferta

PrimeVigilance seeks a dedicated professional to support the ICSR management team in delivering high-quality pharmacovigilance services for global clients. You will process ICSRs across multiple sources, ensure regulatory compliance, and contribute to safety data interpretation and reporting.

The role involves mentoring junior staff, handling SAE/SUSAR activities, and supporting local contact roles as needed. A healthcare-related degree and PV experience are essential for success.

Qualificações

• Life science or biomedical degree with demonstrated PV case processing experience.
• Strong organization, attention to detail and multitasking.
• Excellent time management and planning abilities.
• Proficient in MS Office and data handling.

Responsabilidades

• Provide support to project team activities on behalf of client and company.
• Process ICSRs from all sources in compliance with regulations and SOPs.
• Manage SAE/SUSAR processes, unblinding, reconciliation, and safety plan reviews.
• Protect personal data and ensure quality assurance interactions.
• Handle medical information interactions and MedDRA/WHO coding.
• Produce database outputs and monthly client reports.
• Mentor junior staff and support PV processes for local country roles.

Conhecimentos

Pharmacovigilance case processing

Organization skills

Planning and time management

Technical skills

MS Office

Formação académica

Healthcare related degree

Descrição da oferta de emprego

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

Providing support to other activities undertaken by the project team on behalf of the client and the company

Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):

Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations,PrimeVigilanceprocedures and in accordance with client specific requirements and timelines

SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)

Personal data protection

Product Quality Complaint handling and interaction with Quality Assurance

Medical Information interaction

MedDRA and WHOcoding

Database Outputs and Reports (including data for monthly reporting to clients)

Workflow & resource management

Mentoring and training of new and more junior employees within the department

Support of PV processes related to the ICSR management withinPrimeVigilanceand also toclients

More senior colleague may perform tasks assigned as per SOP to more juniorposition

Performing activities in the scope of ICSR management unit within agreed extent and timeframe

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

Requirements:

• Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing
• Organization skills, including attention to details andmultitasking
• Planning and time management
• Technical skills
• 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.

We look forward to welcoming your application.