PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders and leaders have an unrivalled reputation in the sector with a network of expert associates across the world.

Assures and exerts activities leading to effective cooperation with clients in the area of literature monitoring

Contributes to achieving company´s goals and objectives

Ensures 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 colleague

To assist with the development of literature search strategy

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

To assist with ordering copies of full literature articles for review

To maintain a record and track all literature abstracts screened and full literature article reviewed, with actions taken and the reason

To forward any ICSRs to PV Associates for data entry into the global drug safety database

File other relevant safety related information for use in signal detection and PSURs

To participate in the screening of local non-indexed literature as required

To assist in peer review QC of abstracts

Accessing 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 ICSRs

Uploading the MLM search results and the list of ICSRs in the designated PrimeVigilance Portal area

Reviewing the list of ICSRs daily

Checking 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 EMA

Reporting to the unit head and more senior unit team members, and providing them with regular updates regarding project status and metrics concerning enquiries

To assist with the development and improvement of literature screening processes and procedures

Assisting in departmental regulatory inspection preparedness for the company PV system in the EU and actively participating in PV inspections or audits

Why Should You Apply?

• You want  be involved in a wide range of interesting projects and studies
• You'd like  your  achievements  and hard work to be recognized
• You want to work for a growing company where there are opportunities for advancement
• You'd like to work in a company that has a great reputation with its clients and employees.
• Making a difference to people's lives matters to you