PrimeVigilance
Website:
primevigilance.com
Job details:
Company Description
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
- 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, PrimeVigilance procedures and in accordance with client specific requirements and timelines
- Performing ICSR follow up
- SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
- Reconciliation (clinical, partners)
- Intake, triage, assessment, data entry, follow-up and processing of medical device safety / incident reports.
- Performing quality review/QC of medical device cases, ensuring completeness, accuracy, consistency, coding and adherence to SOPs.
- Personal data protection
- Product Quality Complaint handling and interaction with Quality Assurance
- MedDRA and WHO coding
- 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
Qualifications
- Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
- Demonstrated experience in pharmacovigilance and medical device vigilance
- Good working knowledge of EU MDR (2017/745) and medical device vigilance concepts, including seriousness, reportability, device-relatedness and regulatory reporting requirements.
- Experience with global/European medical device cases and safety databases; ability to identify data discrepancies and ensure cases meet required quality and compliance standards.
- 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.
We look forward to welcoming your application.
Click on Apply to know more.
