Pharmacovigilance Officer

• 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

• 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)

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.