Patient Safety Physician
New
IndiaFull-TimeMiddle
Salary not disclosed
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Job Details
Requirements
- Medical degree (MBBS, MD, or equivalent) from a recognized institution with completion of internship or residency training.
- Strong understanding of clinical medicine, medical terminology, and basic pharmacology principles.
- Interest in pharmacovigilance, drug safety, or clinical research, with exposure considered an advantage but not mandatory.
- Familiarity with global regulatory frameworks such as ICH-GCP, GVP, and other applicable safety guidelines.
- Strong analytical skills with the ability to interpret clinical and safety data effectively.
- Good communication skills, both written and verbal, with attention to scientific and regulatory detail.
- Ability to work within structured procedures while adapting to evolving priorities in a global environment.
- Proficiency in computer systems, including Microsoft Office and web-based applications.
Responsibilities
- Perform medical review and evaluation of adverse event cases from clinical trials, spontaneous reports, literature, and post-marketing sources, ensuring accuracy, completeness, and regulatory compliance.
- Assess seriousness, expectedness, and causality of reported events, and provide medical input for case narratives, coding (MedDRA), and follow-up queries.
- Support preparation and review of aggregate safety reports such as PSURs, PBRERs, DSURs, and other regulatory safety documents.
- Contribute to signal detection, validation, and evaluation activities, including safety trend analysis and medical assessment of emerging risks.
- Provide medical guidance to case processing and safety teams throughout the pharmacovigilance lifecycle under senior supervision.
- Participate in literature review, CSR narrative review, and medical monitoring activities to ensure scientific and clinical accuracy.
- Collaborate with internal and external stakeholders to resolve safety-related queries and support regulatory responses.
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