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Pv Officer (Senior Level Position)

2+ years
Not Disclosed
10 April 24, 2025
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 (Senior Level)
Location: Remote
Employment Type: Full-time
Department: ICSR Management


About the Company:

PrimeVigilance, part of the Ergomed Group, is a mid-size pharmacovigilance service provider founded in 2008. With a global presence across Europe, North America, and Asia, the company specializes in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance supports a wide range of pharmaceutical and biotechnology companies, from small start-ups to large corporations, across all therapeutic areas including medical devices. The company places a strong emphasis on staff development, work-life balance, and mental well-being, fostering a culture focused on quality client service.


Job Responsibilities:

  • Independently process Individual Case Safety Reports (ICSRs) from various sources (post-marketing, clinical trials, devices, and combination products)

  • Ensure compliance with global regulations, PrimeVigilance SOPs, and client-specific guidelines and timelines

  • Handle Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) management independently, including submissions, unblinding, and reconciliation tasks

  • Prepare outputs from safety databases for regulatory and periodic reports (e.g., PBRER, DSUR, PADER)

  • Mentor and support onboarding of new and junior team members

  • Contribute to the development and optimization of internal procedures


Required Qualifications:

  • Life science or healthcare-related degree (e.g., chemistry, biology, biotechnology, biomedical science, veterinary science)

  • Demonstrated expertise in pharmacovigilance case processing

  • Proficient in managing time, multitasking, and problem-solving with keen attention to detail

  • Strong interpersonal and communication skills

  • Advanced proficiency in English (verbal and written), minimum C1 level


What We Offer:

  • Internal training and structured career development programs

  • Emphasis on both personal and professional growth

  • A friendly, collaborative, and supportive work environment

  • Opportunity to work globally with English as the company’s official language

  • A values-based culture built on:

    • Quality

    • Integrity & Trust

    • Drive & Passion

    • Agility & Responsiveness

    • Belonging

    • Collaborative Partnerships