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Pharmacovigilance I

0-2 years
Not Disclosed
10 Feb. 11, 2025
Job Description
Job Type: Remote 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

Experience Level: 0-2 Years

Application Email: careers@clinztech.com


Job Summary

ClinzTech is seeking a Pharmacovigilance Associate I with 0-2 years of experience to support drug safety monitoring and reporting activities. The ideal candidate will assist in the collection, assessment, and documentation of adverse drug reactions (ADRs) and safety reports to ensure compliance with global regulatory requirements.

This entry-level role provides an excellent opportunity for recent graduates or professionals looking to start their career in pharmacovigilance and drug safety.


Key Responsibilities

Adverse Event (AE) Processing & Reporting

  • Collect, analyze, and document adverse drug reactions (ADRs) from healthcare professionals, patients, and regulatory authorities.
  • Enter and manage safety data in pharmacovigilance databases.
  • Ensure timely submission of safety reports to regulatory agencies as per FDA, EMA, and ICH-GCP guidelines.

Regulatory Compliance & Documentation

  • Assist in the preparation and submission of Individual Case Safety Reports (ICSRs) and Periodic Safety Update Reports (PSURs).
  • Ensure accurate and complete documentation in accordance with Good Pharmacovigilance Practices (GVP).
  • Support internal audits and inspections by regulatory authorities.

Signal Detection & Risk Management

  • Help in the identification of potential safety signals and trends from pharmacovigilance data.
  • Collaborate with senior team members to analyze risk-benefit profiles of medicinal products.
  • Participate in risk management planning and safety surveillance activities.

Cross-functional Collaboration

  • Work closely with medical, regulatory affairs, and clinical teams to ensure proper safety monitoring.
  • Communicate effectively with healthcare professionals and patients to collect detailed case information.
  • Assist in the creation of Standard Operating Procedures (SOPs) for pharmacovigilance activities.

Qualifications & Requirements

Education:

  • Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Medicine, Nursing, or a related field.
  • Certification in Pharmacovigilance/Drug Safety is a plus.

Experience:

  • 0-2 years of experience in pharmacovigilance, drug safety, or clinical research.
  • Internship or prior training in pharmacovigilance processes is advantageous.

Technical Skills:

  • Familiarity with pharmacovigilance databases (e.g., Argus, ARISg, Veeva Vault Safety).
  • Basic knowledge of FDA, EMA, ICH-GCP, and WHO pharmacovigilance guidelines.
  • Proficiency in Microsoft Office (Excel, Word, PowerPoint) for documentation and reporting.

Soft Skills:

  • Strong attention to detail and analytical thinking.
  • Excellent written and verbal communication skills.
  • Ability to work effectively in a team-oriented, fast-paced environment.

Preferred Qualifications

  • Understanding of MedDRA coding and WHO drug dictionary.
  • Prior experience in case processing or signal detection.
  • Knowledge of clinical trial safety reporting requirements.

Benefits & Growth Opportunities

  • Competitive salary package.
  • Comprehensive healthcare and wellness benefits.
  • Opportunity to grow into senior pharmacovigilance roles.
  • Hands-on experience with global regulatory compliance and drug safety monitoring.

How to Apply

Interested candidates should email their CVs to careers@clinztech.com with the subject line: Pharmacovigilance Associate I Application – [Your Name].

For more information about ClinzTech, visit Company Website.