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Pharmacovigilance I

0-2 years
Not Disclosed
10 Jan. 18, 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

Position: Pharmacovigilance I (0-2 Years of Experience)
Location: [Location not provided]
Employment Type: [Employment type not specified]
Job Category: Pharmacovigilance
Job Number: [Job number not provided]
Is Job Remote?: [Remote status not specified]
Country: United States


Job Overview

The Pharmacovigilance I role is designed for entry-level professionals with 0-2 years of experience in pharmacovigilance or drug safety. This position will involve supporting the safety monitoring of pharmaceutical products, including collecting, evaluating, and reporting adverse events. The individual in this role will gain experience in pharmacovigilance processes while contributing to the overall safety profile of marketed and investigational drugs.

Essential Job Responsibilities

  • Assist in the collection, review, and processing of adverse event reports in compliance with regulatory requirements.
  • Contribute to the preparation and submission of periodic safety reports, including PSURs (Periodic Safety Update Reports) and DSURs (Development Safety Update Reports).
  • Maintain and update the safety database with accurate and timely information on adverse events and product complaints.
  • Support the medical safety review of adverse event cases and assist in case processing, including coding, data entry, and documentation.
  • Collaborate with cross-functional teams to ensure the effective communication of safety information.
  • Assist in the preparation of risk management plans and risk assessment documents.
  • Ensure compliance with regulatory guidelines and internal pharmacovigilance procedures.
  • Support the team in preparing for regulatory inspections and audits related to pharmacovigilance.
  • Participate in pharmacovigilance projects and initiatives, as needed.
  • Stay updated on global pharmacovigilance regulations, guidelines, and best practices.

Required Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
  • 0-2 years of experience in pharmacovigilance, drug safety, or clinical research.
  • Knowledge of regulatory requirements and guidelines (e.g., ICH, FDA, EMA) related to pharmacovigilance and adverse event reporting.
  • Strong attention to detail with excellent organizational and analytical skills.
  • Ability to effectively communicate both verbally and in writing.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint).
  • Ability to work independently as well as in a team environment.
  • Strong interpersonal skills and the ability to build relationships with colleagues across departments.

Preferred Qualifications

  • Experience with pharmacovigilance databases (e.g., Argus, Veeva, or similar).
  • Knowledge of signal detection and risk management principles.
  • Familiarity with global pharmacovigilance regulations.

Additional Information

[Additional company and diversity-related information, if applicable.]