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.
- Solid 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.

📌 Medical Writer -Aggregate Reporting & Signal Detection (Hyderabad)
🏢 Synapmed
📍 Hyderabad