Job Title: Medical Physician Specialist II
Location: Pune
Category: Clinical
Job ID: 251707
Job Overview:
Provide medical safety expertise, directly and indirectly, to sponsors of drugs, devices, and combination products during the post-marketing period.
Summary of Responsibilities:
Perform primary medical review of cases:
Medical assessment of seriousness, listedness/labeling, causality.
Adverse event coding and narrative review.
Update and document case data and feedback in trackers/tools for workflow management.
Ensure accountability for all assigned deliverables in terms of quality, compliance, and productivity (SLAs and KPIs).
After 1 year of tenure:
Provide training and guidance to case processing teams on medical aspects.
Conduct secondary medical reviews (QC) and retrospective case reviews (QA) to assess quality, identify errors, and suggest improvements.
Engage in aggregate medical review and signal detection/analysis as needed.
Strengthen client relationships and maintain high customer service standards.
Participate in ongoing process improvement activities across the organization.
Minimum Qualifications:
Bachelor’s degree in medical science, MD, DO, or equivalent.
Relevant and equivalent experience may be considered in lieu of educational requirements.
Language Proficiency:
Speaking: English – ILR level 3+ or higher.
Writing/Reading: English – ILR level 4+ or higher.
Minimum Experience Required:
Sound knowledge of medical sciences, diagnosis, therapeutics, drug treatments, and procedures.
Understanding of regulatory requirements in Clinical Research.
Familiarity with ICH-GCP guidelines.
Preferred Qualifications:
Understanding of Pharmacovigilance-related regulatory requirements.
Up to 1 year of pharmaceutical industry experience in pharmacovigilance or clinical research.
1 to 2 years of clinical practice experience.
Physical Demands / Work Environment:
Role may be office-based or remote, as directed by the line manager.
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