Patient Safety Physician or Medical Reviewer || WFH

Added
8 hours ago
Type
Full time
Salary
Salary not provided

Related skills

pharmacovigilance drug safety argus veeva safety arisg
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๐Ÿ“‹ Description

  • Perform medical reviews and assessments of Individual Case Safety Reports (ICSRs), including
  • Conduct signal detection and evaluation using pharmacovigilance databases and statistical tools
  • Analyze aggregate safety data from clinical trials, post-marketing surveillance, and scientific
  • Contribute to the preparation and review of Periodic Safety Update Reports (PSURs), Periodic
  • Participate in signal management activities, including signal validation, prioritization
  • Provide medical expertise for benefit-risk assessments of marketed and investigational products.

๐ŸŽฏ Requirements

  • MBBS degree is mandatory; postgraduate qualifications in Pharmacology, Clinical Research, or Drug
  • At least 5 years of hands-on experience as a Medical Reviewer, with demonstrated expertise in
  • Strong knowledge of pharmacovigilance processes, signal detection methodologies, and global drug
  • Proficiency in safety databases such as Argus, ArisG, Veeva Safety, or similar platforms.
  • Experience with disproportionality analysis and signal detection tools such as Empirica Signal.
  • In-depth understanding of global pharmacovigilance regulations, including ICH E2E, ICH E2D, and GVP

๐ŸŽ Benefits

  • Work arrangement: Fully remote, work-from-home opportunity in India.
  • Employment type: Full-time, permanent position.
  • Location: Mumbai, Maharashtra, India, with remote working flexibility.
  • Salary: Compensation based on previous CTC and experience.
  • Notice period: Open to candidates with any notice period.
  • Career impact: Opportunity to contribute to global patient safety and pharmaceutical risk
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