Medical Writer Aggregate Reporting & Signal Detection
Job Summary:
We are seeking an experienced and detail-oriented Senior Medical Writer– Aggregate Reporting & Signal Detection to lead safety surveillance, aggregate reporting, risk management activities, and clinical trial safety operations. The candidate will be responsible for end-to-end pharmacovigilance processes, signal detection, regulatory compliance, cross-functional coordination, and mentoring team members while ensuring high-quality deliverables within timelines.
Key Responsibilities:
Pharmacovigilance & Safety Surveillance
- Lead scientific, technical, and patient safety input for assigned products, systems, and processes.
- Perform safety surveillance activities including periodic report production and monthly signal detection.
- Deliver scientific and surveillance contributions aligned with organizational and business priorities.
- Independently manage end-to-end PV activities for multiple products and support team development.
- Maintain tracking systems for signals, compliance metrics, safety dates, literature reviews,
training records, and meeting minutes.
Aggregate Reporting & Regulatory Support
- Lead or co-lead preparation of aggregate safety reports including:
- PSUR
- PBRER
- PADER
- DSUR
- Addendums
- Summary Bridging Reports
- Risk Management Plan (RMP) updates
- Review safety database outputs, line listings, and summary tabulations.
- Compile and present safety data for regulatory submissions and client reports.
- Provide scientific and strategic input for health authority queries and submissions.
- Support regulator queries with awareness of global and cross-country regulatory impact.