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Pharmacovigilance Specialist, Case Processing - 12 Month Ftc

0-2 years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./Life science/RN/RPh/PharmD 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

Position Title: Pharmacovigilance Specialist, Case Processing (12-month FTC)
Location: United Kingdom
Employment Type: Full-time
Posted: 10 Days Ago
Job Requisition ID: JR 6500

About ProPharma:
ProPharma has been improving patient health and wellness for over 20 years, providing expertise and advice to empower biotech, medical device, and pharmaceutical organizations. As the world's largest Research Consulting Organization (RCO), ProPharma partners with clients across the product lifecycle through its advise-build-operate model. We offer comprehensive solutions in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and more to accelerate the development and commercialization of medical treatments.

Position Overview:
The Pharmacovigilance (PV) Specialist, Case Processing is responsible for managing individual case safety reports, performing case-level assessments of expectedness, confirming seriousness, writing accurate medical narratives, and generating queries for missing or unclear information. The PV Specialist ensures timely reporting of cases meeting expedited regulatory criteria and adheres to internal guidelines and regulatory standards. The position is designed to provide high-quality service both internally and externally, with opportunities for continuous improvement.

Key Responsibilities:

  • Manage daily case processing of adverse event cases, including coding using MedDRA, assessing seriousness and expectedness at the event and case level.
  • Perform case follow-up activities, identifying necessary information for follow-up collection.
  • Write and review accurate case narratives.
  • Notify clients of case management updates as required.
  • Contribute to the development and delivery of training materials.
  • Highlight discrepancies or concerns to senior case processing staff as needed.
  • Stay up-to-date on global safety regulations for medicines.
  • Perform peer reviews to ensure case quality, consistency, and accuracy.
  • Handle other duties as assigned.

Necessary Skills and Abilities:

  • Strong verbal, written, and interpersonal communication skills.
  • High level of accuracy and attention to detail.
  • Problem-solving abilities and the ability to work independently or within a team.
  • Excellent organization and prioritization skills with the ability to multitask.

Educational Requirements:

  • Required: Bachelor's degree in life sciences.
  • Preferred: Advanced degree, RN, RPh, PharmD, or equivalent.

Experience Requirements:

  • Minimum of two years of relevant experience in pharmacovigilance or a related field.

Why Join ProPharma:
ProPharma is committed to fostering a diverse, inclusive environment where every employee can thrive and succeed. We offer opportunities for personal and professional growth, ensuring our employees feel empowered and valued.

Equal Opportunity Employer:
ProPharma Group provides an inclusive workplace and is an Equal Opportunity Employer, embracing diversity and ensuring a safe space for all employees to succeed.