Pv Associate/Literature

0-2 years

Not Disclosed

Belgrade

10 Nov. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description:
PrimeVigilance, a part of the Ergomed Group, was founded in 2008 by Dr. Miroslav Reljanovic and Dr. Elliot Brown. We offer top-tier, cost-effective, and innovative safety services to pharmaceutical, generic, and biotechnology companies. Our founders and leadership team are highly regarded in the industry, and we have a global network of expert associates who collaborate to provide exceptional service.

Job Description:
PrimeVigilance is looking for a Literature Monitoring Associate to support our pharmacovigilance operations. In this role, you will assist in ensuring effective client cooperation in literature monitoring, contributing to the company's goals and objectives. Your responsibilities will include managing literature screening activities, ensuring compliance with global regulations, and supporting high-quality service delivery.

This position involves working under the guidance of more experienced colleagues, assisting in the development of literature search strategies, conducting literature searches, and supporting literature screening to identify potential Individual Case Safety Reports (ICSRs) and other safety-related information.

Key Responsibilities:

Assist with the development and implementation of literature search strategies.
Participate in weekly and ad hoc literature searches and screening activities.
Identify potential ICSRs and other safety-related information for nominated products.
Assist in ordering copies of full literature articles for review.
Maintain records of all literature screened and articles reviewed, noting actions taken and reasons.
Forward ICSRs to PV Associates for data entry into the global drug safety database.
File other relevant safety information for use in signal detection and Periodic Safety Update Reports (PSURs).
Participate in the screening of local non-indexed literature as required.
Assist with peer review and quality control of abstracts.
Track and download daily MLM search results and ICSRs.
Upload MLM search results and ICSR lists into the designated PrimeVigilance Portal.
Ensure urgent or immediate issues are addressed in a timely manner.
Keep the EMA MLM Literature Screening Tracker up to date.
Provide regular updates to the unit head and senior team members on project status and metrics.
Assist with the development and improvement of literature screening processes and procedures.
Support regulatory inspection preparedness for the company’s PV system in the EU, and actively participate in PV inspections or audits.

Qualifications:

Life sciences or biomedical background (e.g., chemistry, biology, biotechnology, veterinary science).
Previous experience is not required, but a strong desire to learn and contribute to patient safety is essential.
Excellent time management, organizational, and multitasking skills with strong attention to detail.
Strong interpersonal and communication skills.
Advanced English language skills (at least B2, both verbal and written).

Additional Information:
At PrimeVigilance, we prioritize diversity, equity, and inclusion, creating a workplace where people from all cultural backgrounds, genders, and ages can thrive and grow. Our human-first approach drives our continued success and helps improve the lives of those around us.

What We Offer:

Internal training and career development opportunities.
Emphasis on personal and professional growth.
A friendly, supportive work environment.
The opportunity to work with colleagues from around the world, with English as the company language.

Core Values:

Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships

If our values resonate with you, we’d love to welcome your application to PrimeVigilance, where you can help contribute to patient safety and support our mission to improve lives.

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Pv Associate/Literature

Job Description

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