Responsibilities:

• Performs day-to-day Pharmacovigilance (PV) activities within a highly regulated environment and driven by strict timelines.
• PV activities include collection, monitoring, assessment, evaluation, research, and tracking of safety information.
• Coordinates and performs PV activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities.
• Collaborates with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors.
• Assists in the preparation of departmental and project-specific procedures and processes.
• Prepares for and attends audits, kick-off, and investigator meetings.

Essential Functions:

• Participates in on-call duties for specific projects to ensure 24-hour coverage for intake of cases from investigative sites.
• Reviews regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, procedures, and proposals.
• Maintains medical understanding of applicable therapeutic areas and disease states.
• Reviews cases for quality, consistency, and accuracy, including peer reports.
• Prepares and maintains regulatory safety reports.
• Assists with routine project implementation and coordination, including presentations at client/investigator meetings, and review of metrics and budget considerations.
• Mentors less experienced staff.

Application Link

AD