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 DescriptionAssures and exerts activities leading to effective cooperation with clients in the area of literature monitoringContributes to achieving company´s goals and objectivesEnsures that the Literature Screening responsibilities and activities are managed in a cost-efficient manner of the highest quality and in compliance with global regulations and company policies and in accordance with any Pharmacovigilance (PV) agreement.Works under supervision of more experienced colleagueTo assist with the development of literature search strategyTo participate in weekly and ad hoc literature searchesTo participate in weekly and ad hoc literature screening activities to identify potential ICSRs and other relevant safety related information pertaining to nominated productsTo assist with ordering copies of full literature articles for reviewTo maintain a record and track all literature abstracts screened and full literature article reviewed, with actions taken and the reasonTo forward any ICSRs to PV Associates for data entry into the global drug safety databaseFile other relevant safety related information for use in signal detection and PSURsTo participate in the screening of local non-indexed literature as requiredTo assist in peer review QC of abstractsAccessing EV on daily basis and downloading MLM search and MLM ICSR results (excel spreadsheets)Tracking all the MLM search results, MLM ICSRs list downloads and exported ICSRsUploading the MLM search results and the list of ICSRs in the designated PrimeVigilance Portal areaReviewing the list of ICSRs dailyChecking all urgent/immediate issues have been addressed in a timely manner;Keeping the EMA MLM Literature Screening Tracker up to date with the latest information received from the EMAReporting to the unit head and more senior unit team members, and providing them with regular updates regarding project status and metrics concerning enquiriesTo assist with the development and improvement of literature screening processes and proceduresAssisting in departmental regulatory inspection preparedness for the company PV system in the EU and actively participating in PV inspections or audits

Qualifications

Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science), previous experience is not required. 

People who are excited to learn and contribute to patient safety 

Time and issue management, delegation, organization and multitasking skills with good attention to detail 

Strong interpersonal and communication skills 

Advanced English skills, both verbal and written, at least B2 

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. 

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.