Junior PV Officer

• 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 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) 

• Personal data protection 

• Product Quality Complaint handling and interaction with Quality Assurance 

• Medical Information interaction 

• 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 

• Support of PV processes related to the ICSR management within PrimeVigilance and also to clients 

• More senior colleague may perform tasks assigned as per SOP to more junior position 

• 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
• Excellent communication (written and verbal) skills 
• Organization skills including attention to details and multitasking 
• Delegation skills 
• Planning and time management 
• Technical skills 
• Team working 
• Advanced literacy (MS Office) 
• English fluent (spoken written) 

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. Youll 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.

Remote Work :

Yes

Employment Type :

Full-time