Senior Associate, Aggregate Reporting Physician
Core
Develop, review, and maintain high-quality safety and pharmacovigilance documents to support regulatory compliance and safety surveillance for consumer health products.
Role type
Senior Associate, Aggregate Reporting Physician (Pharmacovigilance)
Builds
Periodic Safety Update Reports (PSURs/PBRERs/PADERs), Ad Hoc Safety Reports, DSURs, Signal assessment reports, Aggregate safety reports, Risk management documentation, Health authority responses, Safety narratives, Regulatory submission safety sections.
Domain
Consumer health / Pharmacovigilance / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Synthesize safety data from ICSRs, clinical trials, and post-marketing surveillance; Draft and support preparation of safety reports and narratives; Interpret safety trends and benefit-risk considerations; Support literature surveillance and summarize findings; Contribute to safety conclusions and evidence-based recommendations; Ensure document compliance with global regulations and SOPs; Perform quality control reviews; Support inspection and audit readiness.
Preferred skills
Experience preparing safety and pharmacovigilance documents; Familiarity with global pharmacovigilance regulations and safety reporting requirements; Experience working in a matrixed environment with multiple stakeholders.
Technologies
Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
Responsibilities
Prepare, review, and maintain pharmacovigilance and risk management documents; Synthesize safety information from multiple sources including ICSRs, aggregate data, and epidemiology studies; Collaborate with Safety Scientists and Medical Reviewers to evaluate emerging safety information; Assist in interpreting safety trends and benefit-risk considerations; Support literature surveillance activities; Contribute to the development of safety conclusions and recommendations; Support risk management activities and reports; Ensure compliance with global regulations and company SOPs; Maintain high standards of scientific accuracy and document quality; Perform quality control reviews; Support inspection and audit readiness activities.
Seniority
Mid-Senior level (3–6 years experience)
