Pharmacovigilance Specialist

2+ years
Not Disclosed
10 Jan. 13, 2025
Job Description
Job Type: Full Time Education: PharmD/RPh 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 Case Processing Associate

Company: ProPharma Group


Job Summary

For the past 20 years, ProPharma Group has been a leader in improving the health and wellness of patients by offering consulting expertise in the biotech, medical device, and pharmaceutical industries. As the world’s largest Research Consulting Organization (RCO), ProPharma works with clients throughout the product lifecycle to de-risk and accelerate drug and device programs. We are seeking a Pharmacovigilance Case Processing Associate to join our team and contribute to advancing scientific breakthroughs and introducing new therapies.


Essential Functions

  • Case Processing: Daily processing of adverse event cases (clinical trial and/or post-marketing), including coding using MedDRA, determining seriousness and expectedness of the events and cases.
  • Case Follow-Up: Conduct follow-up activities to gather necessary information.
  • Case Narratives: Create and review detailed case narratives.
  • Client Notifications: Notify clients as needed for effective case management.
  • Training: Support the creation of training materials and contribute to training delivery.
  • Quality Control: Identify discrepancies or concerns in ICSRs (Individual Case Safety Reports) and communicate them to the Principal PV Specialist or Manager, Case Processing.
  • Regulatory Knowledge: Stay up-to-date on global safety regulations for medicines.
  • Peer Reviews: Conduct peer reviews for quality, consistency, and accuracy of case data.
  • Additional Duties: Perform other tasks as required.

Necessary Skills and Abilities

  • Communication: Strong verbal, written, and interpersonal communication skills.
  • Attention to Detail: High accuracy and attention to detail in case processing and documentation.
  • Problem-Solving: Ability to identify and resolve issues in a timely manner.
  • Teamwork: Ability to work independently and collaboratively in a multi-disciplinary team.
  • Organization: Excellent organizational and prioritization skills; capable of multitasking.
  • Pharmacovigilance Knowledge: Basic understanding of pharmacovigilance processes.

Educational Requirements

  • Required: A Bachelor’s degree in life sciences.
  • Preferred: An advanced degree, RN, RPh, PharmD, or equivalent.

Experience Requirements

  • Two years of related work experience in pharmacovigilance or case processing.

Why ProPharma?

We celebrate diversity and create a workplace where everyone can bring their authentic selves to work. We foster an environment of inclusion, innovation, and collaboration and empower our employees to succeed.


ProPharma Group is an Equal Opportunity Employer, committed to diversity, equity, and inclusion. We provide a safe space where employees feel empowered to thrive.


Note: ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please do not contact anyone regarding this posting.