Medical expert evaluating safety and managing risk for projects in clinical development and post-marketing. Collaborating with scientists and clinical teams to support safety assessments and regulatory documentation.
Responsibilities
Provide medical expertise to evaluate safety and manage risk for assigned projects across clinical development and post-marketing settings
Work closely with safety scientists, clinical teams, regulatory colleagues and local stakeholders
Perform medical review and give timely medical advice on safety issues for assigned projects
Lead signal detection and safety evaluation activities and prepare clear safety assessments
Contribute to regulatory safety documentation, including periodic reports and risk management plans
Participate in safety governance and multidisciplinary safety review teams to support decision making
Provide medical input to clinical study safety sections, investigator materials and related documents
Support responses to regulatory queries and safety discussions with external stakeholders
Requirements
Medical degree
Minimum 2 years relevant experience in pharmacovigilance, drug safety, clinical development, or related roles
Practical experience in signal detection, safety evaluation, and benefit-risk assessment
Working knowledge of regulatory safety requirements and pharmacovigilance principles
Strong clinical judgement and the ability to make independent medical assessments
Good written and verbal communication skills in English.
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