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Pv Officer (Senior Level Position)

0-2 years
Not Disclosed
10 Feb. 14, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

PV Officer (Senior Level Position)
Location: Remote
Full-time
Department: ICSR Management
Company: PrimeVigilance (Part of Ergomed Group)


Company Overview:

PrimeVigilance is a leading global pharmacovigilance service provider established in 2008, providing support to pharmaceutical and biotechnology partners worldwide. With a focus on medical information, pharmacovigilance, regulatory affairs, and quality assurance, the company continues to grow and maintain lasting relationships with clients across various therapeutic areas, including medical devices.

PrimeVigilance is dedicated to employee development, well-being, and mental health, ensuring a healthy work-life balance for staff, which is essential to delivering exceptional client service.

Job Overview

The PV Officer will be responsible for managing a variety of case processing services with full accountability. This role involves working independently and within a team to handle safety reports, manage clinical trial data, and ensure compliance with applicable regulations and client requirements.

Key Responsibilities:

  • Case Processing:

    • Process Individual Case Safety Reports (ICSRs) from various sources (post-marketing, clinical trials, device/combination products) while adhering to regulations and company procedures.
    • Cover all steps of the case processing workflow, excluding medical review.
  • SAE/SUSAR Management:

    • Independently manage Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR), including submission, unblinding, and clinical trial reconciliations.
  • Reporting:

    • Prepare database outputs for periodic reports (e.g., PBRER, DSUR, PADER).
  • Mentorship:

    • Train and mentor new or junior employees, focusing on procedure optimization and development.

Qualifications:

  • Education:
    • A degree in a life science or biomedical field (e.g., chemistry, biology, biotechnology, veterinary science).
  • Experience:
    • Proven experience in pharmacovigilance case processing.
    • Strong time management, multitasking, and organizational skills with attention to detail.
  • Skills:
    • Strong interpersonal and communication skills.
    • Advanced English (C1 level or higher).

Why PrimeVigilance?

PrimeVigilance offers a supportive and collaborative work environment with a strong emphasis on diversity, equity, and inclusion. The company values personal and professional growth and provides opportunities for internal career development.

Key Benefits:

  • Career development and training opportunities.
  • Friendly and supportive global team environment.
  • Company values: Quality, Integrity, Trust, Drive, Passion, Agility, Belonging, and Collaborative Partnerships.