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Pv Officer

0 years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm 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 PLC)
Location: Remote
Employment Type: Full-time

Company Overview:

PrimeVigilance, part of Ergomed PLC, is a specialized pharmacovigilance service provider established in 2008. The company has grown organically and now serves pharmaceutical and biotechnology partners across Europe, North America, and Asia. PrimeVigilance specializes in services such as Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance across a wide range of therapy areas, including medical devices. PrimeVigilance fosters a culture focused on employee well-being, offering a work-life balance and career development opportunities.

Job Description:

As a PV Officer at PrimeVigilance, you will be part of the ICSR Management team, providing support for various activities related to pharmacovigilance and safety reporting.

Key Responsibilities:

  • Processing Individual Case Safety Reports (ICSRs) from all sources (post-marketing, clinical trials, devices, etc.) in compliance with regulations, PrimeVigilance procedures, and client-specific requirements.
  • Perform follow-ups on ICSR cases.
  • Manage Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including unblinding, clinical trial reconciliation, and reviewing related documentation such as Safety Management Plans.
  • Handle reconciliation activities (clinical, partners).
  • Manage personal data protection and interact with Quality Assurance for Product Quality Complaints.
  • Perform MedDRA and WHO coding.
  • Conduct first and second case reviews during the pharmacist review step.
  • Support PV processes related to ICSR management and provide assistance to clients.

Additional Responsibilities for Senior Colleagues:

  • Senior team members may perform tasks assigned to junior roles and provide mentorship or training.

Qualifications:

  • Pharmacy degree required.
  • No previous experience required, though a keen interest in pharmacovigilance and patient safety is essential.
  • Strong time management, delegation, organization, and multitasking skills with a keen eye for detail.
  • Excellent interpersonal and communication skills.
  • Advanced English proficiency (B2 or higher, both verbal and written).

Why PrimeVigilance?

PrimeVigilance prioritizes diversity, equity, and inclusion, creating an environment where all employees can grow and contribute. The company values a human-first approach, recognizing that its people are the core of its success in improving patient safety and healthcare.

Core Values:

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

PrimeVigilance offers internal training and career development, a friendly, supportive work environment, and the opportunity to work with global colleagues. The company's commitment to personal and professional growth makes it a great place to develop your career in pharmacovigilance.