Niš, Serbia
56 days ago
Medical Writing Assistant

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

This is an opportunity for new graduates to start and develop their career within drug safety. The Medical Writing Assistant will be working as part of a medical writing team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance

Handling (tracking, submission, e CTD sequencing)  aggregate reports  (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps. Reconciliation activities for all types of received reports Tracking and daily organisation of all departmental activities as per JD

QualificationsAdvanced English  both verbal and written, at least B2 Previous office administration experience is requiredPeople who are excited to learn and contribute to patient safety Life science / bio medical background is preferred but not necessaryTime and issue management, delegation, organization and multitasking skills with good attention to detail Strong interpersonal and communication skills 

Additional Information

Why PrimeVigilance  

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   

Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.  

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