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Clinical Safety Specialist

3+ years
Not Disclosed
10 March 2, 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

Clinical Safety Specialist
Location: Hyderabad, Telangana, India
Reposted: 20 hours ago
On-site | Full-time

About Azurity Pharmaceuticals

Azurity Pharmaceuticals is a specialty pharmaceutical company focused on developing innovative, high-quality medications for underserved patients. With expertise across cardiovascular, neurology, endocrinology, gastro-intestinal, and orphan markets, Azurity is dedicated to improving patient outcomes.

Role Overview

The Clinical Safety Specialist plays a crucial role in monitoring, evaluating, and managing clinical safety data to ensure patient safety throughout drug development and post-marketing phases. This position involves analyzing adverse events, ensuring regulatory compliance, and collaborating with cross-functional teams to assess product risk-benefit profiles.

Key Responsibilities

  • Review and assess adverse event (AE) reports from clinical trials, post-market surveillance, and literature reports.
  • Ensure timely reporting of serious adverse events (SAEs) to regulatory authorities (FDA, EMA, etc.).
  • Assist in preparing clinical safety documents, including Safety Management Plans (SMPs) and Clinical Safety Reports (CSRs).
  • Ensure compliance with global pharmacovigilance regulations (GxP, ICH, FDA, EMA).
  • Support audits and inspections related to drug safety and pharmacovigilance activities.
  • Collaborate with clinical research teams to identify and report adverse events of special interest (AESIs).
  • Contribute to the development of safety surveillance strategies for clinical trials.

Qualifications & Requirements

  • Education: Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or related field (MS, PhD, PharmD preferred).
  • Experience: 3+ years in pharmacovigilance, drug safety, or clinical research.
  • Technical Skills:
    • Knowledge of clinical trial processes and regulatory guidelines.
    • Experience with adverse event reporting, case processing, and regulatory submissions.
    • Proficiency in pharmacovigilance software (e.g., Argus, MedDRA).
    • Strong analytical and communication skills.
  • Physical & Mental Requirements:
    • Ability to sit for long periods.
    • Occasionally lift/move up to 25 pounds.
    • Operate keyboard, phone, and hand-held devices.

Azurity Pharmaceuticals is an Equal Opportunity Employer committed to diversity and inclusion.