PV Associate/Literature

Company Description

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.

Job Description

• 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

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.