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Pv Officer

2+ years
Not Disclosed
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 Officer
Company: PrimeVigilance (part of Ergomed Group)
Location: Remote
Employment Type: Full-time

Company Overview:

PrimeVigilance is a global leader in pharmacovigilance services, part of Ergomed Group. Established in 2008, PrimeVigilance has experienced consistent organic growth and now operates across Europe, North America, and Asia. The company specializes in services such as Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance for pharmaceutical and biotechnology partners. PrimeVigilance provides services across all therapy areas, including medical devices. The company is committed to employee development, well-being, and a healthy work-life balance, recognizing that these factors contribute to high-quality client service.

Job Description:

As a PV Officer, you will be an integral member of the case processing team at PrimeVigilance. Your role involves managing various case processing services, including post-marketing and clinical trial safety reporting, and ensuring compliance with applicable regulations and client requirements. You will work independently on all steps of the case processing workflow, except for the Medical Review.

Key Responsibilities:

  • Process Individual Case Safety Reports (ICSRs) from multiple sources (post-marketing and clinical trials), including device and combination products, ensuring compliance with regulations, PrimeVigilance procedures, and client-specific requirements.
  • Manage Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including submissions, unblinding, and clinical trial reconciliations.
  • Prepare database outputs for periodic reporting (e.g., PBRER, DSUR, PADER).
  • Mentor and train new or junior employees, contributing to procedure optimization and development.
  • Provide support to team members in case processing and ensure the smooth handling of all case management tasks.

Qualifications:

  • Life science or biomedical background (e.g., chemistry, biology, biotechnology, veterinary science).
  • Demonstrated experience in pharmacovigilance case processing.
  • Strong time management, delegation, organization, and multitasking skills with keen attention to detail.
  • Excellent interpersonal and communication skills.
  • Advanced English proficiency (written and spoken), at least C1 level.

Why PrimeVigilance?

PrimeVigilance values diversity, equity, and inclusion, fostering a workplace where people from all cultural backgrounds, genders, and ages can thrive. The company believes in a human-first approach, with employees being the key to its success. By joining PrimeVigilance, you will be part of a team that makes a real impact on patient safety and health.

Core Values:

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

PrimeVigilance offers excellent training, career development, and a supportive work environment. You'll have the opportunity to work with colleagues across the globe in an English-speaking environment, contributing to PrimeVigilance’s mission to improve patient safety and healthcare.

Join PrimeVigilance to make a meaningful contribution to pharmacovigilance and patient care.