Senior Pharmacovigilance Associate (Japanese fluency required)- シニア・ファーマコビジランス・アソシエイト

Company Description

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. 

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. 

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient’s lives. 

Job Description

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them 

Responsibilities:

• 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 
• 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 

Qualifications

Requirements:

• Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science)
• Experience working in Case Processing
• Time and issue management, delegation, organization and multitasking skills with good attention to detail 
• Strong interpersonal and communication skills 
• English language skills and fluency in Japanese 

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.  

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

Our Offer

• Competitive salary
• Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
• Multicultural environment, English as a company language
• Strong emphasis on personal and professional growth
• Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
• Friendly working environment with several social events per year

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!  

• Quality 
• Integrity & Trust  
• Drive & Passion  
• Agility & Responsiveness  
• Belonging 
• Collaborative Partnerships  

We look forward to welcoming your application.