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Pharmacovigilance Specialist

2+ years
Not Disclosed
10 Jan. 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

Job Title: Adverse Event Case Processor
Location: Remote
Company: ProPharma Group

About the Job
For the past 20 years, ProPharma Group has been at the forefront of advancing the health and wellness of patients worldwide. As the largest Research Consulting Organization (RCO), we empower biotech, medical device, and pharmaceutical organizations to confidently advance scientific breakthroughs and bring new therapies to market. Through a unique advise-build-operate model, we offer comprehensive solutions across the product lifecycle, leveraging our deep expertise in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, and medical information.

We are seeking a dedicated Adverse Event Case Processor to join our team and contribute to improving the safety and efficacy of our clients' products. This position is integral to ensuring the accurate and timely processing of adverse event cases across clinical trials and post-marketing surveillance.

Essential Functions

  • Process adverse event cases (clinical trial and/or post-marketing) on a daily basis, including MedDRA coding, and evaluating seriousness and expectedness at both the event and case level.
  • Conduct follow-up activities to identify missing information required for case completion.
  • Create and review case narratives and provide required client notifications for case management.
  • Support the development and delivery of training materials.
  • Highlight discrepancies or areas of concern to the Principal PV Specialist or Case Processing Manager.
  • Maintain up-to-date knowledge of global pharmacovigilance safety regulations.
  • Perform peer reviews of cases to ensure quality, consistency, and accuracy.
  • Perform additional duties as assigned.

Necessary Skills and Abilities

  • Strong verbal, written, and interpersonal communication skills.
  • High attention to detail and accuracy.
  • Ability to resolve problems promptly and effectively.
  • Ability to work both independently and as part of a collaborative, multidisciplinary team.
  • Excellent organizational skills and the ability to prioritize and multitask.
  • Basic knowledge of pharmacovigilance principles.

Educational Requirements

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

Experience Requirements

  • Two years of related work experience.

Diversity and Inclusion
ProPharma Group is committed to fostering a diverse and inclusive workplace where every employee can thrive. We value creativity, innovation, and collaboration, encouraging employees to embrace their authentic selves. As an Equal Opportunity Employer, we provide a supportive environment that empowers all individuals to succeed.

Please note that ProPharma Group does not accept unsolicited resumes from third-party recruiters.