PV Officer (Medical Device & Product experience)

📋 Description

• Performing activities in the scope of ICSR management unit within agreed extent and timeframe
• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable
• Performing ICSR follow up
• SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management
• Reconciliation (clinical, partners)
• Intake, triage, assessment, data entry, follow-up and processing of medical device safety /

🎯 Requirements

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in
• Demonstrated experience in pharmacovigilance and medical device vigilance
• Good working knowledge of EU MDR (2017/745) and medical device vigilance concepts, including
• Experience with global/European medical device cases and safety databases; ability to identify data
• Excellent communication (written and verbal) skills
• Organization skills, including attention to details and multitasking

🎁 Benefits

• When you join Ergomed Group, you make a difference by helping to bring safe and effective
• You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance
• We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a
• 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.