Job Description
- 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.