Associate, Regulatory Registration and Compliance

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. 

• Initial submission and maintenance of medicinal data on Authorised Medicinal Products and Development Medicinal Products in eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)

• EudraVigilance registration process and user access management as per client's request

• Registration of organizations with Organisation Management Service (OMS) as per client's request

• Creating accounts on MHRA submissions and ICSR submissions portals and perform user management as per client's request

• Prepare, collect, review regulatory information and documents to support submissions to FDA, EMA and national authorities (CTA/INDs, MAAs/NDAs/BLAs) for initial authorisation and maintenance, in compliance with the applicable regulations

• Ensure compliance with company procedures, processes, training records, systems and any other tools 

• Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS

• Participate in preparation for audits/inspections and provide department representation for assigned projects as required

• Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
• Good planning and organizational skills
• Good written and verbal communication skills to clearly and concisely present information
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Good attention to detail
• Excellent self-motivation skills
• Proficiency in English, both written and verbal
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint