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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: Sarajevo, Bosnia and Herzegovina
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 provides high-quality, cost-effective safety services to pharmaceutical, generic, and biotechnology organizations globally. Known for its expertise and a network of professionals, PrimeVigilance remains a trusted partner in the pharmacovigilance sector.

Job Description:

The PV Associate/Literature will work closely with the Literature Screening team to ensure compliance with global regulations and company policies in literature monitoring. This role involves identifying potential Individual Case Safety Reports (ICSRs) and other safety-related data while supporting process improvements under the supervision of senior team members.

Key Responsibilities:

  • Literature Monitoring:
    • Develop and participate in weekly/ad-hoc literature searches and screening activities.
    • Screen local non-indexed literature when required.
  • Data Management:
    • Maintain records of screened abstracts, reviewed articles, actions taken, and their rationale.
    • Forward identified ICSRs to PV Associates for database entry.
    • File relevant safety data for signal detection and Periodic Safety Update Reports (PSURs).
  • Quality Control:
    • Assist with peer review and quality control of abstracts.
    • Keep the EMA MLM Literature Screening Tracker updated.
  • System Processes:
    • Access EV daily to download, track, and upload MLM search results and ICSRs into designated company portals.
  • Process Improvement:
    • Assist in developing and refining literature screening procedures.
  • Regulatory Readiness:
    • Support the team in preparation for regulatory inspections and audits.
    • Participate actively in pharmacovigilance system inspections within the EU.
  • Reporting:
    • Provide regular project updates to unit heads and senior team members.

Qualifications:

  • Education:

    • Background in life sciences, biomedical, or healthcare-related fields (e.g., chemistry, biology, biotechnology, or veterinary science).
    • No prior experience required, but enthusiasm for learning and contributing to patient safety is essential.
  • Skills:

    • Time management, organization, and multitasking with attention to detail.
    • Strong interpersonal and communication skills.
    • Advanced English proficiency, verbal and written, minimum B2 level.

What We Offer:

  • Training & Development:
    • Comprehensive training and career advancement opportunities.
  • Growth-Oriented Environment:
    • Emphasis on personal and professional development.
  • Workplace Culture:
    • Supportive and friendly working atmosphere.
    • Opportunity to collaborate with a diverse global team, with English as the primary language.

Core Values:

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

At PrimeVigilance, we foster an inclusive, human-centered workplace where everyone can thrive and contribute to improving global healthcare outcomes.

If these values resonate with you, we encourage you to apply and join us on this meaningful journey!