01Overview
Job purpose The Sr. Executive Aggregate Reports Writer (Pharmacovigilance) will be responsible for leading and delivering endtoend aggregate safety report activities across the product lifecycle. This role ensures the accurate preparation, scientific integrity, and timely global submission of DSURs and PSURs/PBRERs in compliance with international and regional regulatory requirements. The position supports regulatory decisionmaking, inspection readiness, and continuous benefitrisk evaluation through highquality safety analyses, crossfunctional collaboration, and subject matter expertise in global pharmacovigilance reporting standards.Duties and responsibilities Lead endtoend preparation, scientific review, and timely global submission of aggregate safety reports, including DSURs, PSURs/PBRERs, and other periodic reports, in compliance with ICH E2F, ICH E2C(R2), EU GVP Modules, and regional regulatory requirements.Serve as the Aggregate Report Subject Matter Expert (SME), providing scientific, regulatory, and strategic safety input across the product lifecycle.Perform comprehensive cumulative safety evaluations, including assessment of AEs, SAEs, SUSARs, signals, emerging safety issues, and benefitrisk profiles using clinical and postmarketing data.Integrate and interpret clinical, nonclinical, epidemiological, and realworld safety data to deliver clear, highquality scientific analyses within aggregate reports.Author, review, and finalize key report components such as executive summaries, safety evaluations, actions taken for safety reasons, and benefitrisk assessments.Review and interpret line listings, summary tabulations, cumulative and interval data, and statistical outputs to identify trends and clinically meaningful findings.Coordinate closely with crossfunctional stakeholders including Clinical Development, Medical Affairs, Epidemiology, Biostatistics, Regulatory Affairs, Nonclinical, and Data Management to ensure alignment on safety conclusions and risk management actions.Ensure consistency and alignment across aggregate reports and related safety documentation, including RMPs, Investigators Brochures (IB), CCDS/RSI, and signal assessment documents.Manage reporting timelines, milestones, and dependencies, ensuring ontime, compliant submissions across multiple products and regions.Address health authority questions, assessment reports, and postsubmission commitments, including preparation of responses and followup safety analyses.Maintain inspection readiness by ensuring adherence to SOPs, work instructions, documentation standards, and company quality systems, support regulatory inspections, audits, and internal PV quality reviews.Drive continuous improvement by updating SOPs, templates, job aids, and best practices related to aggregate reporting.Utilize safety databases and reporting tools (e.g., Argus Safety, Argus Aggregate Reporting, PV Works or equivalent) to support data review and report generation.Mentor and provide scientific guidance to junior team members, deliver training sessions, and promote consistency and excellence in aggregate reporting practices.Provide strategic safety input to governance forums, safety review boards, and development teams to support informed, datadriven decisionmaking.QualificationsMasters degree/ bachelors degree in pharmacy, Medicine, Life Sciences, or a related scientific discipline required.Minimum 8 years of experience within a Pharmacovigilance or Drug Safety function.46 years of handson experience in the authoring, review, and submission of aggregate safety reports, including DSURs, PSURs/PBRERs, and PADERs.Proven experience supporting global regulatory submissions across multiple regions.Strong knowledge of ICH guidelines (E2C[R2], E2F) and global pharmacovigilance regulatory requirements.Indepth understanding of clinical development phases (IIV) and the investigational and postmarketing product lifecycle.Demonstrated ability to interpret regulatory feedback, health authority questions, and inspection findings related to aggregate reports.Excellent medical writing, data interpretation, signal management, and benefitrisk assessment skills.Experience working with safety databases and reporting tools, with Argus Safety required.Demonstrated strong analytical and problemsolving skills, excellent attention to detail and quality focus, with the ability to manage multiple timelines and crossfunctional stakeholders effectively.Working conditionsThis position is fully officebased (onsite).Job may require availability beyond standard working hours to support priority business needs, audits, or inspections.Physical requirementsThis is a largely sedentary role.Direct ReportsN/A .
