Drug Safety Physician

soterius· Clinical Safety & Pharmacovigilance
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📍 Noida, UP, IndiaFULL TIME

About this role

Role Overview:

Responsible for providing medical review and clinical assessment of adverse event cases identified through literature monitoring within a Pharmacovigilance program. The role will apply clinical judgment in the assessment of literature-derived safety information, support case processing and safety evaluation activities, and ensure appropriate identification and escalation of potential safety concerns in accordance with applicable regulations, guidelines, SOPs, and client requirements.

Qualification:

  • MBBS, MD or equivalent medical qualification.
  • Candidates with relevant Pharmacovigilance, Drug Safety, Medical Review, or Literature Monitoring experience are preferred.
  • Fresh medical graduates with strong clinical knowledge and an interest in Pharmacovigilance may also be considered.

Experience:

  • 2+ years of relevant experience in Pharmacovigilance, Drug Safety, Medical Review, or Literature Monitoring preferred.

Key Responsibilities:

  1. Perform medical review of adverse event cases identified from scientific literature, including assessment of clinical information and relevance to the reported safety event.
  2. Conduct medical assessment of literature-derived ICSRs, including causality, seriousness, expectedness, and other applicable medical assessments in accordance with SOPs and client requirements.
  3. Review literature case information and narratives to ensure appropriate clinical interpretation, completeness, and consistency.
  4. Conduct line listing review of non-serious cases, as applicable, in accordance with program SOPs and medical review requirements.
  5. Apply clinical judgment to identify medically significant information, complex cases, unusual events, and potential safety concerns, and escalate appropriately.
  6. Provide medical input to product safety assessments and other Pharmacovigilance activities, as required.
  7. Support benefit-risk evaluation and provide medical input for safety assessments.
  8. Provide medical input to aggregate reports and other relevant safety documents.
  9. Support the assessment and preparation of responses to medical aspects of regulatory queries and client requests.
  10. Collaborate with Literature Monitoring and Pharmacovigilance teams to ensure appropriate medical interpretation, assessment, and processing of literature-derived safety information.
  11. Ensure medical review activities are performed accurately and in compliance with applicable regulations, guidelines, SOPs, and quality standards.
  12. Contribute to the identification and assessment of potential safety signals or emerging safety concerns from literature and escalate them through appropriate channels.
  13. Participate in quality reviews, process improvement initiatives, and relevant medical training activities as required.
  14. Perform other responsibilities as assigned by Management.

Key Skills:

  • Medical review of literature-derived safety cases
  • ICSR medical assessment
  • Causality, seriousness, and expectedness assessment
  • Literature case assessment and clinical interpretation
  • Line listing review
  • Benefit-risk evaluation
  • Aggregate report medical input
  • Product safety assessment
  • Safety signal identification and escalation
  • Regulatory query support
  • Strong clinical judgment and analytical skills
  • Good written and verbal communication skills
  • Attention to detail and commitment to quality and compliance

Frequently Asked Questions

Is the salary disclosed for the Drug Safety Physician position at soterius?
The salary for this Drug Safety Physician role at soterius is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Drug Safety Physician position at soterius located?
This Drug Safety Physician role at soterius is based in Noida, UP, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Drug Safety Physician role at soterius full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Drug Safety Physician role in the Clinical Safety & Pharmacovigilance department at soterius.
Which team or department does the Drug Safety Physician at soterius belong to?
This Drug Safety Physician position is part of the Clinical Safety & Pharmacovigilance department at soterius. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Drug Safety Physician position at soterius?
Click the "Apply Now" button on this page. You will be redirected to soterius's official application portal hosted on keka where you can submit your application directly.
When was the Drug Safety Physician job at soterius posted?
This Drug Safety Physician position at soterius was posted on Aug 27, 2026. Apply as soon as possible — early applications are often reviewed first.
Drug Safety Physician
soterius
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