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Principal Pharmacovigilance Specialist, Case Processing

4+ years
Not Disclosed
10 Jan. 3, 2025
Job Description
Job Type: Full Time Education: 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

Job Title: Pharmacovigilance (PV) Specialist
Company: ProPharma Group
Location: Remote
Position Type: Full-Time


About ProPharma Group

ProPharma has been at the forefront of improving global patient health for over 20 years. As the world's largest Research Consulting Organization (RCO), ProPharma empowers pharmaceutical, biotech, and medical device companies to advance scientific breakthroughs and bring new therapies to market. By offering end-to-end consulting solutions across the entire product lifecycle, ProPharma de-risks and accelerates high-profile drug and device programs. The company brings deep domain expertise in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology.


Position Overview

The Pharmacovigilance (PV) Specialist will serve as a subject matter expert within ProPharma, providing oversight and guidance to ensure the quality and compliance of pharmacovigilance activities. This role will involve handling complex cases, mentoring staff, and collaborating across multiple teams to ensure accurate and timely management of safety data. The PV Specialist will oversee case management, perform case reviews, contribute to the development of training materials, and ensure adherence to global safety regulations.


Key Responsibilities

PV Oversight & Direction:

  • Provide subject matter expertise to enhance client service, both internally and externally.
  • Oversee the development of project-specific documents such as Working Practices, Work Instructions, and Safety Data Exchange Agreements.
  • Serve as a resource for the Case Processing team on complex cases and escalated inquiries.
  • Handle case follow-up activities, identifying necessary information for collection.
  • Create and review case narratives and provide necessary client notifications.
  • Contribute to the development of training materials and participate in training delivery.
  • Identify and escalate discrepancies related to Individual Case Safety Reports (ICSRs).

Mentorship & Case Reviews:

  • Perform peer reviews of cases for quality, consistency, and accuracy.
  • Provide Health Care Professional (HCP) reviews when required.
  • Mentor and train less experienced staff to ensure high-quality work standards.

Regulatory Knowledge & Compliance:

  • Stay updated on global pharmacovigilance regulations and safety reporting requirements.
  • Ensure compliance with internal and external safety regulations.

Qualifications

Education:

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

Experience:

  • Required: Minimum of 4 years of related work experience in pharmacovigilance.

Skills & Abilities:

  • Strong verbal, written, and interpersonal communication skills.
  • Excellent project management abilities with attention to detail.
  • Advanced problem-solving skills with the ability to resolve issues promptly.
  • Ability to work independently and collaboratively within a multidisciplinary team.
  • In-depth knowledge of pharmacovigilance and safety reporting processes.
  • Proficient in using PV systems such as Oracle Argus Safety, ARISg, or other safety databases.
  • Highly self-motivated to maintain efficiency and manage multiple projects simultaneously.

Why Work with ProPharma?

  • Inclusive Culture: ProPharma promotes a diverse, equitable, and inclusive workplace where all employees can be their authentic selves.
  • Career Growth: Opportunities to mentor, grow professionally, and make significant contributions to the pharmacovigilance field.
  • Work Environment: A holistic approach where employees are empowered to succeed and innovate.

ProPharma Group is an Equal Opportunity Employer and is committed to diversity, equity, and inclusion. We provide a safe space where employees can thrive, collaborate, and contribute to groundbreaking work.


How to Apply

Interested candidates are encouraged to submit their applications via the ProPharma career portal. ProPharma does not accept unsolicited resumes from third-party recruiters.


This position description provides a detailed overview of the responsibilities, qualifications, and skills for the Pharmacovigilance Specialist role at ProPharma. Let me know if you need any further details or adjustments!