Patient Safety Physician in India at Jobgether
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Job Description
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Patient Safety Physician in India.
This role sits at the heart of global drug safety and pharmacovigilance activities, ensuring that patient wellbeing remains central throughout the clinical development lifecycle. You will contribute to the medical evaluation of safety data across clinical trials, post-marketing surveillance, and literature sources. The position involves close collaboration with cross-functional teams, including safety scientists, regulatory experts, and clinical operations professionals. You will review adverse event data, assess clinical relevance, and support regulatory reporting activities in alignment with global standards. Working in a highly regulated and impact-driven environment, you will help ensure compliance while improving the safety profile of innovative therapies. This is a remote-based opportunity offering exposure to global healthcare projects and evolving regulatory landscapes. The role is ideal for medically trained professionals looking to transition or grow in pharmacovigilance within a structured, learning-focused setting.
- 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.
- 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.
- Remote-friendly work structure offering flexibility in work arrangements.
- Opportunity to work in a global clinical research and drug safety environment.
- Exposure to international regulatory standards and advanced pharmacovigilance practices.
- Continuous learning opportunities in clinical development and patient safety domains.
- Collaborative, science-driven work culture focused on improving patient outcomes.
- Career development potential within a growing and specialized medical safety field.