Junior PV Officer

Ergomed; Maryland; Presencial; USD 60 000 - 90 000; Tempo integral

Resumo da oferta

Ergomed invites applications for a Junior PV Officer role focused on pharmacovigilance case processing, ICSR handling, and safety signal management. Based in Maryland, the position offers exposure to global projects within PrimeVigilance and mentorship from senior team members.

You will support ICSR processing, SAE/SUSAR management, data protection, and reporting, with opportunities to grow in RA & PV network activities.

Qualificações

• Life science / healthcare related degree and demonstrated experience in Pharmacovigilance.
• Excellent communication (written and verbal) skills.
• Organization skills, including attention to details and multitasking.
• Delegation skills and planning/time management.
• Technical skills and teamwork.
• Advanced literacy (MS Office).
• English – fluent (spoken, written).

Responsabilidades

• Provide support to project team activities for the client and company.
• Handle ICSR management scope within agreed extent and timeframe.
• Process IC SRs from all sources in compliance with regulations and client requirements.
• Perform ICSR follow-up and SAE/SUSAR management.
• Handle reconciliation (clinical, partners) and data protection.
• Interact with Medical Information and Quality Assurance.
• Prepare database outputs and monthly client reports.
• Mentor and train junior staff; support PV processes and LCPPV role as needed.

Conhecimentos

Pharmacovigilance

ICSR processing

Communication

Time management

Teamwork

MS Office

English fluency

Attention to detail

Formação académica

Biomedical 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.

The Junior PV Officer role is a mid senior role that requires previous experience inPharmacovigilance case processing.It includes:

• 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

• Performing ICSR followup

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

• Reconciliation (clinical, partners)

• 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

Requirements:

• Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance
• Excellent communication (written and verbal)skills
• Organization skills, including attention to details andmultitasking
• Delegation skills
• Planning and time management
• Technical skills
• Team working
• Advanced literacy (MS Office)
• English – fluent (spoken, written)

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.