Senior Scientist - Aggregate Reporting

Overview

Senior Scientist to develop, review and maintain pharmacovigilance and safety documents for consumer health products, synthesizing data from multiple sources to support safety surveillance and regulatory compliance. This is an individual contributor role with no direct reports.

What you'll do

• Prepare, review and maintain pharmacovigilance and risk management documents for consumer health products.
• Synthesize safety information from ICSRs, aggregate safety data, clinical trial safety data, post-marketing surveillance data, epidemiology studies, published literature, signal detection and evaluation activities, benefit-risk assessments and Health Authority Assessment Reports.
• Draft and support the preparation of Periodic Safety Update Reports (PSURs/PBRERs/PADERs), Ad Hoc Safety Reports, Development Safety Update Reports (DSURs), signal assessment reports, aggregate safety reports, risk management documentation, health authority responses, safety narratives, safety sections of regulatory submissions, and safety surveillance reports and presentations.
• Provide analysis and evaluation for the Safety Management Teams (SMT).
• Collaborate with Safety Scientists, Medical Reviewers and others to evaluate emerging safety information and communicate findings effectively.
• Assist in the interpretation of safety trends, potential signals and benefit-risk considerations.
• Support literature surveillance activities and summarize relevant safety findings.
• Contribute to the development of safety conclusions and evidence-based recommendations.
• Support the preparation, review and analysis of risk management activities and reports.
• Ensure all documents comply with global pharmacovigilance regulations, company SOPs and applicable guidance documents.
• Maintain high standards of scientific accuracy, consistency, grammar and document quality.
• Perform quality control reviews of safety documents and ensure timely delivery of assigned projects.
• Support inspection and audit readiness activities through accurate documentation practices.

What you'll need

• Advanced degree required: PharmD, PhD, MD, MPH, MS, or equivalent scientific discipline.
• 8-10 years of experience in pharmacovigilance, drug safety, medical writing, regulatory writing, or related pharmaceutical, consumer health or medical device industries.
• Familiarity with global pharmacovigilance regulations and safety reporting requirements.
• Experience working in a matrixed environment with multiple stakeholders.
• Strong understanding of clinical research methodologies, epidemiology and biostatistics, evidence-based medicine, regulatory and scientific communication requirements, and safety and benefit-risk assessment principles.
• Expertise in literature evaluation and scientific data interpretation.
• Ability to critically analyze multiple complex scientific information and identify key insights to drive product safety.
• Excellent medical writing, editing and proofreading skills.
• Exceptional grammar, attention to detail and document quality standards.
• Strong analytical and critical thinking capabilities.
• Effective project management and organizational skills.
• Strong verbal and written communication skills.
• Ability to work independently while managing multiple priorities and deadlines.

Nice to have

• Experience preparing safety and pharmacovigilance documents.

Details

• Location: Bengaluru, Karnataka, India.
• Works closely with Drug Safety, Medical Affairs, Regulatory Affairs, Clinical Development, Quality and R&D teams.