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Sr. Drug Safety Associate

2+ years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time 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
Job Description:
As a staff member, you will contribute to our culture of continuous process improvement, focusing on streamlining processes to add value to our business and meet client needs. The role involves up to 10% domestic and/or international travel.

Key responsibilities include:

  • Reviewing and processing serious adverse events (SAEs), spontaneously reported adverse reactions, and other medically related information in compliance with ICON SOPs, Study Specific Procedures, regulatory requirements, and sponsor processes.
  • Maintaining accurate safety tracking systems and project files.
  • Attending project team meetings and teleconferences as required.
  • Providing safety-related support to investigational sites and ICON personnel.
  • Assisting with training/mentoring new staff and identifying out-of-scope activities.
  • Reviewing clinical and diagnostic data for safety issues and liaising with sponsors and investigative sites.
  • Serving as the lead DSA for local or regional projects and assisting with study-specific procedures.

Key Skills Required:

  • Pharmacovigilance, Eudravigilance, Oracle Argus, Aggregate Reporting

Experience: 4-10 years
Industry: Pharma / Biotech / Clinical Research
Role Category: R&D & Training
Employment Type: Permanent, Full-time

Interested candidates can send their profiles to contact@covalenttrainings.com or reach us at +91-9848733309 / +91-9676828080 for further assistance.