Website:
synapmed.com
Job details:
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.
Clinical Trial Safety
- Manage clinical trial pharmacovigilance activities including:
- SAE reconciliation
- SUSAR reporting
- DSUR contributions
- Safety surveillance
- Compliance with ICH-GCP and applicable regulations
Signal Management
- Review literature and safety data for potential signals.
- Author signal evaluation reports, aggregate reviews, and assessments for indeterminate signals.
- Support benefit-risk evaluation and risk minimization strategies.
Quality & Compliance
- Review regulatory documents before submission to ensure quality and accuracy.
- Share quality feedback, track defects, and ensure adherence to TAT and SLA commitments.
- Participate in audits, inspections, and CAPA activities.
- Ensure compliance with SOPs, global regulations, and internal quality standards.
Required Qualifications:
- Master’s in Pharmacy, Life Sciences, or healthcare degree such as BDS, MBBS, Nursing, or equivalent.
- Relevant experience in Pharmacovigilance / Drug Safety / Clinical Safety.
Required Skills & Competencies:
- Strong understanding of global PV regulations: FDA, US, EU, ICH, GCP.
- Expertise in aggregate report writing and signal detection.
- Knowledge of safety databases and literature surveillance tools.
- Strong analytical and decision-making skills.
- Excellent written and verbal communication skills.
- Attention to detail and deadline management.
- Ability to work independently and in cross-functional teams.
- Proficiency in MS Office and relevant safety systems.
- Strong interpersonal and stakeholder management skills.
Preferred Experience:
- Experience handling post-marketing and clinical trial safety activities.
- Experience in mentoring teams or leading deliverables.
- Exposure to audits, inspections, and regulatory interactions.
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