Pv Associate/Literature

0-1 years

Not Disclosed

Belgrade

10 Dec. 5, 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: Belgrade, Serbia
Employment Type: Full-time
Department: Literature

Company Overview:

PrimeVigilance, a part of Ergomed Group, is a specialized pharmacovigilance service provider founded in 2008. The company offers top-quality, cost-effective safety services to pharmaceutical, generic, and biotechnology companies globally. PrimeVigilance has built a reputation for excellence with a network of expert associates worldwide.

Job Description:

The PV Associate/Literature role involves working in the Literature Screening team to ensure high-quality, efficient literature monitoring and screening processes, which is essential for identifying potential Individual Case Safety Reports (ICSRs) and other safety-related information. The role works under supervision, contributing to the development and improvement of screening processes and assisting in regulatory inspection preparedness.

Key Responsibilities:

Literature Screening & Monitoring: Contribute to the development of literature search strategies, participate in weekly/ad-hoc literature searches, and assist in screening to identify potential ICSRs or safety information.
Tracking & Recording: Maintain accurate records of screened abstracts, reviewed articles, actions taken, and reasons for those actions.
Data Entry: Forward relevant ICSRs to PV Associates for entry into the global drug safety database.
Signal Detection: Contribute to the filing of safety-related information for use in signal detection and PSURs.
MLM Search Results: Download, track, and upload MLM search results, ensuring they are processed in the PrimeVigilance Portal.
QC & Peer Review: Assist in the peer review and quality control of abstracts.
Regulatory Inspection Support: Assist with departmental inspection preparedness and actively participate in PV inspections or audits.

Qualifications:

Education: Life science or biomedical background, e.g., degree in chemistry, biology, biotechnology, or veterinary science.
Experience: No previous experience is required, though candidates should be excited to learn and contribute to patient safety.
Skills:
- Time and issue management, organization, and multitasking abilities with attention to detail.
- Strong interpersonal and communication skills.
- Advanced English (verbal and written), at least B2 level.

Why PrimeVigilance?

PrimeVigilance values diversity, equity, and inclusion, and aims to create a human-centric workplace where individuals from all cultural backgrounds can thrive. The company offers:

Training and career development opportunities.
A strong emphasis on personal and professional growth.
A friendly and supportive working environment.
The opportunity to work with colleagues globally, with English as the company language.

Core Values:

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

PrimeVigilance is dedicated to improving the lives of those around us, and if you resonate with these values, this could be a great opportunity for you.

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Pv Associate/Literature

Job Description

Company Overview:

Job Description:

Qualifications:

Why PrimeVigilance?

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