Aggregate Reports Specialist

Job Summary

To support drug safety and risk management initiatives, the contract Aggregate Reports Specialist will manage aggregate safety reports and Risk Management Plan activities while collaborating with cross-functional teams in a remote capacity.

Key responsibilities:

• Manage and lead the authoring of aggregate safety reports, including PSURs and DSURs, in partnership with cross-functional leads
• Oversee the management of pharmacovigilance line listings and identify gaps in aggregate report processes for improvement
• Collaborate with Safety Physicians and study teams to analyze safety issues and support signal detection and data mining activities

Required qualifications:

• Degree in a medical or healthcare-related discipline (e.g., MSN/RN, PharmD, MD)
• 3-5 years of experience in the pharmaceutical industry, particularly in drug safety or pharmacovigilance
• Knowledge of Argus and Arisg safety databases, as well as signal detection tools like Empirica
• Experience with global pharmacovigilance regulatory requirements across various regions
• Strong analytical and scientific writing skills, with experience in developing data displays and dashboards