Patient Safety Physician

About the role

The Patient Safety Physician will sit at the core of global drug safety and pharmacovigilance activities, ensuring patient wellbeing throughout the clinical development lifecycle. This remote position offers exposure to clinical trials, post‑marketing surveillance and literature monitoring for innovative therapies.

Key responsibilities

• Perform medical review and evaluation of adverse event cases from clinical trials, spontaneous reports, literature and post‑marketing sources.
• Assess seriousness, expectedness and causality, and provide input for case narratives, MedDRA coding and follow‑up queries.
• Support preparation and review of aggregate safety reports such as PSURs, PBRERs, DSURs and other regulatory documents.
• Contribute to signal detection, validation and safety trend analysis.
• Provide medical guidance to case processing and safety teams under senior supervision.
• Participate in literature review, CSR narrative review and medical monitoring activities.
• Collaborate with internal and external stakeholders to resolve safety‑related queries and support regulatory responses.

Required profile

• Medical degree (MBBS, MD or equivalent) with internship or residency completed.
• Strong understanding of clinical medicine, medical terminology and basic pharmacology.
• Interest in pharmacovigilance, drug safety or clinical research.
• Familiarity with global regulatory frameworks such as ICH‑GCP and GVP.
• Excellent analytical, written and verbal communication skills.
• Ability to work within structured procedures while adapting to evolving priorities.

Required skills

• MedDRA coding
• ICH‑GCP knowledge
• GVP (Good Pharmacovigilance Practices) knowledge

What we offer

• Remote‑based work with global healthcare project exposure.
• Learning‑focused environment to develop pharmacovigilance expertise.