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.  

POSITION SUMMARY

PV associate in literature must participate in Global Literature Screening process, by providing review and assessment of the scientific and medical literature, according to procedures and regulatory requirements.

CORE RESPONSIBILITIES

• · To participate in weekly and ad hoc literature searches
• · To participate in weekly and ad hoc literature screening activities to identify potential ICSRs and other relevant safety related information pertaining to nominated products for use in signal detection and aggregate reports, and document the process in literature screening tracker
• · To plan and conduct the review of literature references
• · To order copies of full literature articles for review
• · To order translation of literature reference if applicable
• · To forward any ICSRs for data entry into the global drug safety database in timely manner
• · To inform QCer that review is done
• · To participate in sensitivity testing
• · To monitor mailbox
• · To populate and maintain Literature Weekly Tracker in timely manner
• · To populate ACTi Time accurately and in timely manner
• · To check if all urgent/immediate issues have been addressed in a timely manner
• · To report to senior team members and unit head, and provide them with regular updates regarding project status and metrics concerning enquiries
• · Assisting in departmental regulatory inspection preparedness for the company PV system and actively participating in PV inspections or audits

SPECIFIED ADDITIONAL RESPONSIBILITIES

• · To participate in Regulatory Agency Screening
• · Accessing and tracking EV MLM search and MLM ICSR results

• Life science graduate, pharmacy, nursing, other healthcare related qualification 
• 1-2 years of work experience in pharmacovigilance 
• Organization skills, including attention to detail and multitasking · Ability to work in team
• To have time and issue management skills 
• Japanese and English - advanced (spoken, written) 
•  Advanced MS Office, Teams and Excel skills

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. 

We offer: 

• Training and career development opportunities internally  
• Strong emphasis on personal and professional growth 
• Friendly, supportive working environment 
• Opportunity to work with colleagues based all over the world, with English as the company language 

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.