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Pharmacovigilance I

0-2 years
Not Disclosed
10 March 17, 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

Pharmacovigilance I
Company: Clinztech
Employment Type: Full-time
Schedule: [Day Shift]

Job Responsibilities:

  • Monitor, collect, and analyze adverse drug reactions (ADRs) and adverse event (AE) reports.

  • Assist in the processing, assessment, and documentation of safety cases.

  • Ensure compliance with pharmacovigilance regulations and guidelines.

  • Conduct literature reviews to identify potential safety concerns.

  • Support the preparation of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).

  • Assist in signal detection activities to identify emerging safety risks.

  • Maintain accurate and up-to-date pharmacovigilance databases.

  • Coordinate with regulatory authorities and stakeholders for safety reporting.

  • Participate in safety audits and inspections.

Requirements:

  • Education: Bachelor's/Master’s in Pharmacy, Life Sciences, Medicine, or a related field.

  • Experience: 0-2 years in pharmacovigilance, drug safety, or clinical research.

  • Skills:

    • Knowledge of pharmacovigilance regulations (ICH-GCP, FDA, EMA guidelines).

    • Familiarity with safety databases (Argus, ArisG, or similar tools).

    • Strong analytical and medical writing skills.

    • Ability to interpret and evaluate safety data.

    • Attention to detail and excellent communication skills.

Preferred Qualifications:

  • Certification in Pharmacovigilance or Drug Safety is a plus.

  • Experience in case processing and regulatory submissions.

Why Join Clinztech?

  • Work with a leading clinical research and pharmacovigilance team.

  • Competitive salary and career growth opportunities.

  • Exposure to global pharmacovigilance practices.