Performs and may oversee day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information.
Effectively collaborates with various parties such as: project team members, client contacts, investigators and adverse event/ reporters, and third party vendors.
Works independently to perform day-to-day PV activities. May participate in on call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits.
Mentors less experienced staff.
Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
Maintains medical understanding of applicable therapeutic area and disease states.
Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations.
Conducts assessment and peer review of literature abstracts/articles for adverse events, special situation events, signal-relevant and aggregate safety report-relevant safety information, and analysis of similar events (AOSE) for both developmental and market-authorized products.
Serves as the primary point of contact for low, medium and high complexity literature projects (e.g. high complexity projects with more than 5 products, projects involving review for ICSRs, signal-relevant, aggregate safety report-relevant safety information and/or AOSE, and projects with high volume of citations).
Ensures that assigned literature surveillance tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations.
Participates in departmental initiatives.
May prepare for and attend audits, inspections and bid defenses.
