Job Overview: We are seeking an experienced Aggregate Reporting Specialist to join our Pharmacovigilance team. The ideal candidate will be responsible for the preparation and submission of aggregate safety reports, including Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and other regulatory submissions. This role is crucial in ensuring compliance with global regulatory requirements and enhancing our understanding of the safety profile of our products.Key Responsibilities: Prepare, review, and submit aggregate safety reports (PSURs, DSURs, etc.) in compliance with regulatory requirements and internal procedures. Collaborate with cross-functional teams to gather and analyze data from various sources, including clinical trials, spontaneous reports, and literature. Conduct comprehensive risk assessments and benefit-risk evaluations to support aggregate reporting. Ensure timely and accurate submission of reports to regulatory authorities and internal stakeholders. Maintain knowledge of current regulations, guidelines, and industry best practices related to aggregate reporting. Participate in audits and inspections, ensuring readiness and compliance with regulatory standards. Assist in the development and maintenance of standard operating procedures (SOPs) related to aggregate reporting processes. Stay informed on emerging safety issues and trends relevant to the company’s products.Qualifications: Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree (e.g., MS, PhD) preferred. 4+ years of experience in pharmacovigilance or drug safety, with a focus on aggregate reporting. Strong understanding of global regulatory requirements (e.g., ICH, FDA, EMA) for aggregate reporting. Proficient in data analysis and interpretation, with experience using relevant software/tools. Excellent written and verbal communication skills, with attention to detail. Strong organizational skills and the ability to manage multiple priorities effectively. Experience with pharmacovigilance databases (e.g., ARGUS, VigiBase). Knowledge of statistical analysis methods and their application in pharmacovigilance.
Job Title
Aggregate Reporting Specialist – Pharmacovigilance