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Sr Drug Safety Associate I

2+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time 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

Job Title: Sr Drug Safety Associate I – ICSR Quality Review & Regulatory Report Submission
Company: Vizen Life Sciences Pvt. Ltd.
Job Type: Full-Time
Experience: 4-6 Years
Location: [Not specified]


Job Description:

We are seeking a Sr Drug Safety Associate I with 4-6 years of experience in Pharmacovigilance (PV), specifically focused on ICSR Quality Review and Regulatory Report Submission. The role involves working with the Argus database to approve, schedule, and submit regulatory reports to health authorities, business partners, and affiliates, ensuring compliance with internal and external timelines.


Key Responsibilities:

  • Regulatory Report Submission: Approve and schedule the submission of Individual Case Safety Reports (ICSRs) to health authorities, business partners, and affiliates.
  • Adherence to Timelines: Ensure adherence to both internal and external timelines to maintain regulatory reporting compliance.
  • Quality Review: Perform ICSR quality reviews to ensure accuracy and compliance with regulatory requirements.
  • Scheduling and Approval: Schedule and approve regulatory reports based on reporting obligations.

Job Requirements:

  • Experience: 4-6 years of relevant experience in Pharmacovigilance (PV), particularly in ICSR Quality Review and Regulatory Report Submission.
  • Educational Qualification: B.Pharm or M.Pharm.
  • Skills and Competencies:
    • Strong knowledge of Pharmacovigilance (PV) regulations and guidelines for health authority submissions.
    • Expertise in quality assurance and compliance.
    • Excellent attention to detail and analytical skills.
    • Effective communication and time management abilities.

Apply Now

If you meet the above qualifications and are ready to contribute to regulatory report submissions in the pharmaceutical industry, apply now.