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Principal Pharmacovigilance Specialist, Case Processing

4+ years
Not Disclosed
10 Jan. 13, 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

Pharmacovigilance (PV) Subject Matter Expert

Company: ProPharma Group
Location: Remote


About ProPharma Group

ProPharma Group has been a leader in advancing health and wellness for over 20 years, providing expertise to help biotech, med device, and pharmaceutical organizations confidently bring scientific breakthroughs and new therapies to market. As the world’s largest Research Consulting Organization (RCO), ProPharma supports its clients through an advise-build-operate model, covering the full product lifecycle. With deep expertise in regulatory sciences, clinical research, pharmacovigilance, medical information, and R&D technology, ProPharma delivers comprehensive, customizable solutions to accelerate and de-risk the most high-profile drug and device programs.


Role Overview

The Pharmacovigilance Subject Matter Expert will play a pivotal role in leading and supporting ProPharma's Pharmacovigilance services. This position provides expertise in case processing, regulatory compliance, and safety management, contributing to the success of high-profile pharmaceutical programs. The role includes overseeing the development of key project documents, training delivery, case follow-up activities, and peer reviews of safety cases, all while maintaining a deep understanding of global safety regulations.


Key Responsibilities

  • Oversight and Direction: Serve as a subject matter expert (SME) for PV, providing guidance and enhancing client services both internally and externally.
  • Documentation Development: Oversee the creation of essential documents, including Working Practices, Work Instructions, and PV Agreements.
  • Case Processing Support: Serve as a resource for the Case Processing team for complex cases and escalated inquiries, and assist in follow-up activities.
  • Case Review and Narratives: Create and review case narratives and provide client notifications as required.
  • Training Development: Contribute to the development and delivery of training materials for the team.
  • Mentoring and Leadership: Mentor and train less experienced staff to ensure high standards of case management.
  • Regulatory Knowledge: Keep up-to-date with global pharmacovigilance regulations for medicines.
  • Peer Review: Conduct peer reviews of safety cases to ensure quality, consistency, and accuracy.
  • Health Care Professional (HCP) Review: Perform HCP reviews as required.
  • Collaboration: Highlight discrepancies and concerns to senior PV team members.

Necessary Skills and Abilities

  • Communication Skills: Strong verbal, written, and interpersonal communication skills for interacting with clients and colleagues.
  • Project Management: Excellent project management skills to handle multiple projects effectively.
  • Attention to Detail: High level of accuracy and attention to detail in case processing and documentation.
  • Problem-Solving: Advanced problem-solving skills and the ability to address issues quickly.
  • Collaboration: Able to work independently and as part of a multidisciplinary team.
  • Organization: Excellent organizational skills with the ability to prioritize tasks.
  • Pharmacovigilance Expertise: In-depth knowledge of pharmacovigilance practices, including regulatory requirements and safety case management.
  • PV Systems Knowledge: Advanced knowledge of PV systems such as Oracle Argus Safety, ARISg, or other safety databases.
  • Self-Motivation: High self-motivation to maintain efficiency and productivity while managing multiple projects and clients.

Educational Requirements

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

Experience Requirements

  • Minimum four years of related work experience in pharmacovigilance or a related field.

Why ProPharma?

ProPharma fosters a diverse, inclusive, and innovative environment where employees are empowered to be their authentic selves and succeed in their roles. The company values creativity, collaboration, and entrepreneurial spirit, offering a safe and supportive space for professional growth.


Additional Information

  • Remote Position
  • Note: ProPharma does not accept unsolicited resumes from third-party recruiters. Please refrain from contacting anyone regarding this posting.

This position is ideal for experienced pharmacovigilance professionals who are looking to expand their expertise while contributing to high-impact projects. If you're passionate about drug safety and regulatory compliance, we encourage you to apply!