Medical Writer -Aggregate Reporting & Signal Detection (Hyderabad)

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: - Masters 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. .