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Pv Associate/Literature

0-1 years
Not Disclosed
10 Dec. 6, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Job Title: PV Associate/Literature
Location: Niš, Serbia
Employment Type: Full-time
Department: Literature

Company Overview:

PrimeVigilance, part of the Ergomed Group, was founded in 2008 by Dr. Miroslav Reljanovic and Dr. Elliot Brown. The company is renowned for delivering holistic, cost-effective safety services to pharmaceutical, generic, and biotechnology companies. With an exceptional reputation and a global network of professionals, PrimeVigilance remains a trusted leader in pharmacovigilance (PV).


Job Description:

As a PV Associate/Literature, you will support the Literature Monitoring team in ensuring compliance with global regulations and company standards while contributing to patient safety. This role involves screening scientific literature for safety-related data, supporting process improvement, and collaborating with international teams.


Key Responsibilities:

Literature Monitoring & Screening:

  • Participate in weekly and ad-hoc literature searches and screening activities.
  • Identify potential Individual Case Safety Reports (ICSRs) and other relevant safety data.
  • Support the screening of local non-indexed literature as required.

Data & Record Management:

  • Maintain accurate records of literature abstracts, full articles reviewed, actions taken, and justifications.
  • Forward identified ICSRs for entry into the global safety database.
  • File relevant safety data for use in signal detection and Periodic Safety Update Reports (PSURs).

Quality Control:

  • Assist with peer review and quality checks of abstracts.
  • Update the EMA MLM Literature Screening Tracker regularly.

System Processes & Improvement:

  • Access EV systems daily to download and upload MLM search results and ICSR data.
  • Develop and refine literature search strategies and processes.

Regulatory Readiness:

  • Support the team during regulatory inspections and audits.
  • Assist in EU pharmacovigilance system inspections.

Reporting:

  • Provide updates to unit heads and senior team members regarding project metrics and statuses.

Qualifications:

Education & Experience:

  • Degree in life sciences, biomedical, or healthcare-related fields (e.g., biology, biotechnology, chemistry, veterinary science).
  • No prior experience required—open to individuals eager to learn and contribute to patient safety.

Skills:

  • Time management, organization, multitasking, and attention to detail.
  • Strong interpersonal and communication skills.
  • Proficiency in English (minimum B2 level, verbal and written).

What We Offer:

Training & Development:

  • Comprehensive training and career advancement opportunities.

Growth-Oriented Workplace:

  • Emphasis on personal and professional growth.
  • Friendly and supportive working environment.

Global Collaboration:

  • Work with colleagues across the globe, with English as the company language.

Our Core Values:

At PrimeVigilance, we are committed to fostering an inclusive and empowering workplace, guided by our core values:

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

If our mission and values resonate with you, we invite you to apply and join us in making a difference in global healthcare!